Category: US Food and Drug Administration

Source: US Food and Drug Administration

Summary

Company Announcement Date:
July 17, 2026
FDA Publish Date:
July 17, 2026
Product Type:
Food & BeveragesAllergens
Reason for Announcement:

Recall Reason Description
May contain undeclared milk in the form of sodium caseinate

Company Name:
Fayus, Inc.
Brand Name:

Brand Name(s)
Ola-Ola

Product Description:

Product Description
Pounded Yam (2lb, 4lb, 5lb, 10 lb)

Company Announcement
Fayus Inc., doing business as Yusol International Foods (Sacramento, CA) is expanding its recall of OLA-OLA POUNDED YAM to include product sizes 2lbs, 4lbs, 5lbs, and 10lbs due to product labeling omission of an undeclared milk allergen for sodium caseinate, a milk derivative. People who have an allergy, or severe milk sensitivity to milk, run the risk of a serious or life-threatening allergic reaction if they consume this product. No illness or injuries have been reported in connection with this issue.
The recall was initiated, and later expanded, as a result of an internal investigation discovering that some packaged OLA-OLA POUNDED YAM had been distributed in packaging that did not disclose the presence of sodium caseinate – derived from milk, a milk allergen, due to a temporary breakdown in the company’s production and packaging processes. In addition, The Canadian Food Inspection Agency (CFIA) sampled the 4lb product and confirmed the omission of the milk allergen from the product label. A subsequent investigation, and CFIA sampling of the 10lb product, revealed that additional packaging sizes may be affected.
This recall includes the following product packaging sizes with the expiration dates between November 2028 through May 2029: 2lbs (0.907kg), 4lbs (1.815kg), 5lbs (2.267kg), and 10lbs (4.53kg). OLA-OLA POUNDED YAM was distributed through distribution outlets in the African and Caribbean markets between December 2025 – May 2026 in Canada, Australia and the following United States:

California
Georgia
Illinois
New Jersey
New York
Texas

The recalled products are packaged in a clear plastic bag. This recall does not apply to packaging that declares the milk allergen. See example packaging below for correct and incorrect packaging. Consumers should check expiration dates on the front of the packaging, as well as the allergen declaration labeling, to determine if they have the affected product.
Questions or Exchange Requests:
Distribution outlets may exchange the affected product for correctly packaged and labeled product, or for a relabeled/reconditioned package of the product. Consumers with a milk allergy, or severe sensitivity to milk, should not consume the affected product. Fayus Inc. apologizes for any inconvenience and remains committed to the safety and quality of its products. Consumers who have purchased the products and have questions may contact the company at info@yusolfood.com or call 916-383-1124 Monday – Friday 11am – 3pm PST.
Link to Initial Press Release

Company Contact Information

Product Photos

Content current as of:
07/17/2026

Regulated Product(s)

Topic(s)

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Source: US Food and Drug Administration

Summary

Company Announcement Date:
July 13, 2026
FDA Publish Date:
July 13, 2026
Product Type:
Food & BeveragesAllergens
Reason for Announcement:

Recall Reason Description
May Contain Undeclared Peanuts

Company Name:
Khong Guan Corporation
Brand Name:

Brand Name(s)
Khong Guan Corporation

Product Description:

Product Description
Glutinous Rice Balls with Black Sesame Filling

Company Announcement
Khong Guan Corporation is recalling specific lots of “Glutinous Rice Balls with Black Sesame Filling” because they may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reactions if they consume these products.
Product Details:

Product: Glutinous Rice Balls with Black Sesame Filling
Size/Packaging: 14.1 oz bag
UPC: 6-908791-000053
Date Code: 10/19/2027
Distribution: Weee!, Xin Wang Market, Garden Fresh Farmer’s Market, Boss Supermarket. CA, HI, NJ, TX – online and retail stores.

No illnesses have been reported to date. The recall was initiated after a customer reported suspected peanut content in the product, which had been distributed in packaging that did not disclose the presence of peanuts.
Consumers who purchased the affected product are urged not to consume it and should return it to the place of purchase for a full refund.
Consumers with questions may contact Khong Guan Corp. at 1-877-889-8968.

Company Contact Information

Consumers:
Khong Guan Corp.
1-877-889-8968

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Content current as of:
07/13/2026

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Source: US Food and Drug Administration

For Immediate Release:
July 10, 2026

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model. The proposed rule would also clarify registration requirements for certain foreign establishments that manufacture drugs, including active pharmaceutical ingredients, that indirectly enter the U.S. drug supply.
This action is another step forward in the FDA’s coordinated effort to help ensure Americans have reliable access to safe, quality medicines by strengthening domestic pharmaceutical manufacturing, and ensuring that regulatory frameworks keep pace with innovation.
Distributed manufacturing establishments operate using a “hub-and-spoke” model, with a central quality oversight hub and multiple equivalent manufacturing units at different locations. Currently, regulations require each manufacturing unit in such a network to register separately, creating unnecessary administrative burdens. Under the proposed rule, distributed manufacturing establishments could register as a single establishment. Units could be added, relocated or removed through a streamlined update process, and companies would be required to notify the FDA in advance of any unit relocation, closing a gap in the agency’s real-time oversight.
“The FDA is proposing changes to our establishment registration regulations that would reflect how distributed manufacturing actually works — as one single establishment,” said Michael Davis, M.D., Ph.D., Acting Director of FDA’s Center for Drug Evaluation and Research. “The proposed changes would make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are being made.”
The proposed rule would also clarify registration and drug listing requirements for certain foreign drug manufacturing establishments. Currently, some foreign establishments that manufacture drugs (including components of drugs, such as active pharmaceutical ingredients) only for distribution to other foreign establishments may not be registered with the FDA, limiting the agency’s visibility into upstream supply chains. By aligning our regulations to the statutory requirements, this proposed rule would make it clearer that these establishments must register with the FDA and report on the drugs they produce, giving the FDA greater ability to detect and respond to potential safety concerns.
“When an active ingredient in a medicine reaches an American patient, the FDA should be able to trace exactly where it came from,” said Dr. Davis. “Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve.”
If finalized, the proposed rule is expected to reduce registration costs for distributed manufacturing companies and generate long-term efficiencies for both industry and the agency. It builds on a series of administration actions aimed at revitalizing American pharmaceutical manufacturing, improving supply chain transparency, and reducing vulnerabilities in the drug supply chain.
The proposed rule is available here.

Consumer:888-INFO-FDA

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

Content current as of:
07/10/2026

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Source: US Food and Drug Administration

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The FDA has received an increasing number of reports of pets accidentally overdosing on Apoquel Chewable (oclacitinib chewable tablets), a flavored chewable medicine approved only for dogs.
Accidental overdoses have been reported in both dogs and cats. However, cats are more likely than dogs to experience serious side effects if they take too much of the medication. As of April 2, 2026, there have been 259 reports of overdose in dogs and 64 reports in cats since the medication was approved by the FDA in June 2023.

How You Store the Medication is One Step to Your Pet’s Safety 
Store flavored medications like Apoquel Chewable carefully. Keep the medication in its original packaging and in a location that pets cannot access, such as a high cupboard or cabinet with a child-resistant lock. 
You can learn more about safe medication storage on our webpage Properly Store Medications to Keep Your Pet Safe.
You can also ask your veterinarian about switching to the unflavored, non-chewable Apoquel tablet. 

What Is Apoquel Chewable Used For 
Apoquel Chewable is a flavored, chewable tablet containing the active ingredient oclacitinib and requires a prescription from a veterinarian. It is used to control itching in dogs with skin allergies and to treat a chronic skin condition called atopic dermatitis, which is similar to eczema in people.
Apoquel Chewable is safe and effective for dogs older than 1 year when used at the recommended dose. Apoquel Chewable is not approved for cats.

Why Apoquel Chewable Can Be a Hazard 
The pork-liver flavoring in Apoquel Chewable makes the medication appetizing and easier to give to dogs. However, this flavoring can also be highly desirable to some dogs and cats, causing them to eat large amounts of the medication if they can reach it. 
In many cases, the dog or cat ingested a full or almost-full bottle of Apoquel Chewable.
An overdose of Apoquel Chewable can be life-threatening for both dogs and cats, but cats tend to develop more severe signs. Signs of an overdose in dogs and cats may include:

Vomiting and diarrhea 
Lethargy (low energy or decreased activity)
Redness of the eyes and swelling around the eyes
Effects on the heart, brain, kidneys, and liver 

These signs usually appear within 24 hours after an overdose.

What to Do if Your Pet Overdoses on Apoquel Chewable 
If you suspect your pet has accidentally overdosed on Apoquel Chewable, call your veterinarian immediately.  
If you can’t reach your regular veterinarian, contact a local emergency animal hospital or an animal poison control center.
Two animal poison control centers in the United States are available 24 hours a day, 365 days a year. These services charge a fee, but their veterinarians can provide immediate expert advice.

When you talk to a veterinarian, it helps to have the following information ready:

Your pet’s weight
The amount of medication ingested
When the medication was consumed
The product packaging 

Report the Incident! 
The FDA encourages you to report the incident to Zoetis, the manufacturer of Apoquel Chewable ( Customer Care Hub | Zoetis ). 
For more information about reporting problems or side effects with an animal drug, see the FDA’s Report a Problem page.
Reporting problems with animal drugs helps the FDA monitor the safety of products after they are on the market and more easily identify potential safety concerns. 
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Source: US Food and Drug Administration

For Immediate Release:
July 01, 2026

The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β thalassemia (TDT). This is the first gene therapy approved for patients aged 2 years and older with SCD.  
Casgevy has been previously approved for the treatment of patients aged 12 years and older with SCD with recurrent VOCs or TDT.  
“With today’s decision, pediatric patients as young as 2 years of age can now access a critical additional treatment option to treat these debilitating, life-threatening diseases,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research (CBER). “The FDA is committed to prioritizing and speeding up the review of products that address critical U.S health priorities through expedited review programs, including the FDA Commissioner’s National Priority Voucher (CNPV) Pilot Program. These initiatives are designed to advance therapies for diseases with significant unmet medical needs, enabling faster access to innovative treatments while upholding the FDA’s rigorous gold-standard requirements for safety and effectiveness.”  
SCD affects red blood cells (RBCs), which contain hemoglobin, a protein that transports oxygen throughout the body. SCD can cause various symptoms and health issues, including episodes of severe pain called sickle cell crises or VOCs.    
Thalassemia is a genetic blood disorder that causes the body to have an abnormally low level of hemoglobin, resulting in reduced oxygen delivery to the body’s tissues. In some cases, individuals require regular blood transfusions to maintain adequate levels of functional hemoglobin.  
Casgevy is a gene therapy consisting of the patient’s own (autologous) hematopoietic (blood) stem cells, administered as a one-time single dose for intravenous infusion. The cells are edited using CRISPR/Cas9, a type of genome editing technology, and then engrafted in the body’s bone marrow. CRISPR/Cas9 can be directed to a specific spot in DNA, where it cuts the genetic material so that DNA can be accurately removed, added, or replaced. In patients with severe SCD, this treatment increases a type of hemoglobin which is called fetal hemoglobin (HbF). This helps prevent RBCs from forming into abnormal sickle shapes and addresses the underlying cause of disease, thereby eliminating VOCs.  
In patients with TDT, treatment increases HbF levels and total hemoglobin levels, hence eliminating dependence on regular RBC transfusions.
Full myeloablative conditioning, a high-intensity preparatory treatment given to patients before they receive a stem cell transplant or gene therapy, is administered prior to treatment with Casgevy.
“These disorders carry a heavy burden for children and their families, affecting growth, development, and long-term health in profound ways,” said Megha Kaushal M.D., MSc, Acting Deputy Director of the Office of Therapeutic Products in CBER and pediatric hematologist. “Grounded in the scientific evidence that earlier treatment reduces the risk of lasting end-organ damage, making this therapy available to younger patients opens a critical window for intervention and gives these children a meaningful chance at a healthier future.”
The safety and effectiveness of Casgevy in patients aged 5 years to less than 12 years with SCD were evaluated in a clinical trial which included 11 patients. All eight patients who were evaluable for efficacy achieved the primary efficacy outcome of VF12 (no protocol-defined severe VOCs for at least 12 consecutive months within the first 24 months after infusion with Casgevy).  
The efficacy and safety of Casgevy in patients 5 years to less than 12 years of age with TDT were evaluated in a trial of 15 patients. Eight of the nine efficacy evaluable patients with TDT achieved transfusion independence for 12 consecutive months, with a median duration of transfusion independence of 20.1 months.  
Based on product characteristics and clinical study data, extrapolation to the younger pediatric age population was granted to expand the indication to 2 years of age and above for both conditions.    
The most common adverse reactions were mucositis (inflammation of mucous membranes) and febrile neutropenia (fever associated with low levels of a type of white blood cell called neutrophils) in patients with SCD and in patients with TDT, and decreased appetite in patients with SCD. Additionally, the prescribing information contains warnings for neutrophil engraftment failure, delayed platelet engraftment, hypersensitivity reactions, and off-target genome editing risk (refers to the possibility that the CRISPR/Cas9 editing process may make unintended edits to parts of the genome other than the intended target site).  
The approval decision was granted just 53 days after filing and represented the eighth approval selected for the Commissioner’s National Priority Voucher (CNPV) pilot program. The FDA granted Casgevy Orphan Drug, regenerative medicine advanced therapy (RMAT), and Fast Track designations.  
The FDA granted the approval to Vertex Pharmaceuticals, Incorporated.

Consumer:888-INFO-FDA

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

Source: US Food and Drug Administration

English 
La dentición es una fase normal de la infancia y no debe tratarse con remedios homeopáticos, como las pastillas para la dentición o los medicamentos recetados y de venta libre (OTC, por sus siglas en inglés) que se frotan en las encías.
La benzocaína, un anestésico local, es el ingrediente activo de varios productos de venta libre para el cuidado de la salud bucal como Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel y Topex. Estos productos no son útiles para tratar las encías doloridas debido a la dentición, ya que se eliminan de la boca del bebé en cuestión de minutos. Es más, pueden ser peligrosos.
El uso de geles, aerosoles, ungüentos, soluciones y pastillas de benzocaína para tratar el dolor en la boca y en las encías puede dar lugar a una afección grave —y a veces mortal— llamada metahemoglobinemia, en la cual la capacidad de transportar oxígeno de los glóbulos rojos se reduce enormemente.
Es por ello que la  Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de EE.UU. advierte a los padres y los cuidadores que los productos que contienen benzocaína no deben usarse para tratar el dolor de la dentición en niños o bebés.
Qué puede hacer por los niños durante la dentición
En promedio, los bebés comienzan la fase de dentición alrededor de los 4 a 7 meses de edad, y tienen un total de 20 “dientes de leche” a los 3 años. 
Según la Academia Americana de Pediatría (AAP, por sus siglas en inglés), ntre los síntomas ocasionales de la dentición están: irritabilidad moderada, fiebre baja, babeo y una ansiedad por morder algo duro.
Puesto que la dentición tiene lugar durante un período de muchos cambios en la vida del bebé, con frecuencia se le achacan, erróneamente, congestionamiento, tos, vómito, diarrea y alteraciones del sueño..
Si las encías de su hijo están inflamadas y sensibles:

frote o masajee suavemente las encías con el dedo
dele una mordedera de goma firme para que la mordisquee

Asegúrese de que la mordedera no esté congelada. Si el objeto es demasiado duro, puede lastimarle las encías. Los padres de familia deben supervisar a sus hijos para que no se atraganten accidentalmente con la mordedera.
Evite las cremas y geles para la dentición
Como padre, abuelo o cuidador, puede tratar de calmar a un bebé que le están saliendo los dientes frotando medicamentos anestésicos en las encías del niño. Sin embargo, la FDA advierte contra el uso de cualquier tipo de medicamento tópico para tratar el dolor de la dentición en los niños, incluidos los geles y las cremas de venta libre, así como el uso de pastillas homeopáticas para la dentición. Ofrecen poco o ningún beneficio y se asocian con un riesgo grave. La metahemoglobinemia puede ocurrir cuando se usa algún anestésico local.
Los adultos también pueden verse afectados
Los productos de venta libre para el cuidado de la salud bucal con benzocaína también son ampliamente utilizados por los adultos. Los médicos y los dentistas con frecuencia usan sprays que contienen benzocaína para adormecer las membranas mucosas de la boca y la garganta durante las intervenciones médicas y quirúrgicas, como los ecocardiogramas transesofágicos, las endoscopías, la intubación y los reemplazos de tubos de alimentación. Sin embargo, la FDA no ha aprobado los sprays de benzocaína para estos usos.
Hable con su médico sobre el uso de benzocaína y otros anestésicos locales, especialmente si padece alguna cardiopatía, tiene una edad avanzada, es fumador o tiene problemas respiratorios como asma, bronquitis o enfisema. Estas afecciones pueden aumentar el riesgo de sufrir complicaciones relacionadas con la metahemoglobinemia.
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Source: US Food and Drug Administration

For Immediate Release:
June 17, 2026

The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older. Approved in time for the 2026–2027 flu season, this approval reflects the Trump Administration’s commitment to increasing the availability of generic drugs.
“Today’s approval marks a meaningful milestone for the treatment of influenza,” said Iilun Murphy, MD, Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research. “Expanding patient access to drugs and improving their ease of use are critical public health imperatives, particularly given that influenza alone accounts for millions of illnesses in the U.S. each year.”
Generic baloxavir marboxil tablets may be used for:

Treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours, and who are otherwise healthy or at high risk of developing influenza-related complications; and
Post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza.

Baloxavir marboxil tablets are contraindicated in patients with a known history of hypersensitivity reactions to baloxavir marboxil or any of its ingredients. Baloxavir marboxil carries warnings such as increased incidence of treatment-emergent resistance in patients less than 5 years of age.
The most common side effects include diarrhea, bronchitis, nausea, sinusitis, and headaches. Healthcare providers should review the full prescribing information for complete safety and dosing information.
In the U.S., nine out of 10 prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients. Learn more about the FDA Drug Competition Action Plan.
Xofluza is a registered trademark of Genentech, Inc. FDA approved Norwich Pharmaceuticals, Inc.’s application for generic baloxavir marboxil tablets.
Related Information

Related Information

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

Content current as of:
06/17/2026

Regulated Product(s)

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Source: US Food and Drug Administration

June 16, 2026
The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing interruptions in the supply of stereotactic breast biopsy needles because of recent supplier issues. The manufacturing disruption in supply of these devices is expected to impact patient care and may require adjustments to the clinical management of patients indicated to undergo a breast biopsy. The FDA currently expects the duration of this shortage to extend through the end of Q1 (March) 2027. The FDA recommends health care providers consider strategies to conserve the use of stereotactic breast biopsy needles.
On January 2, 2026, Hologic issued a customer letter stating that all lots of the Brevera Breast Biopsy System Disposable 9 Gauge Needle were being removed because there is a risk of metal and plastic particles being dislodged from the device during use. If particulate matter originating from the device is left behind in a patient post-biopsy, potential adverse effects such as foreign body reaction, hematoma/hemorrhage, and infection may arise. If particulate matter enters a biopsy specimen, an additional biopsy procedure may be required due to contamination of the specimen.
Recommendations
The FDA recommends health care providers experiencing interruptions or shortages in supply of stereotactic breast biopsy needles develop strategies to conserve their use. Providers should use their clinical judgment when developing and implementing conservation strategies.
In developing strategies to preserve the supply for patients at highest risk, please consider the following:
Needle Conservation Strategies

Expand supplier networks with vendor diversification.
Diversify and utilize all needle gauges and lengths to avoid dependence on limited “standard” inventory.
Utilize prior-generation devices where clinically appropriate.
Limit unnecessary opening/wasting of devices.

Inventory and Supply Chain Management Tips

Centralize inventory tracking across breast imaging sites.
Monitor inventory with a daily/weekly inventory dashboard available to all radiologists performing biopsy procedures.
Forecast utilization trends based on scheduled biopsy volumes and distribute biopsy needles appropriately across health systems/facilities.

Patient Communication/Clinical Care

Communicate delays transparently.
Offer alternative biopsy locations/sites where biopsy needles are available, if alternative biopsy devices are not suitable.
Maintain focus on minimizing delay for cancer diagnosis/treatment.

Background
On March 13, the FDA updated the Medical Device Shortages List to include stereotactic breast biopsy needles (product code KNW). Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires the FDA to maintain a publicly available, up-to-date list of the devices the FDA has determined to be in shortage.
FDA Actions
The FDA is:

Working with manufacturers and providers to monitor the current situation to help ensure stereotactic breast biopsy needles remain available for patients when medically necessary.
Evaluating potential solutions for mitigating patient impact.
Informing the public as new information becomes available.

The FDA reviews each notification received under section 506J of the FD&C Act and uses this information, along with any additional details about the supply of and demand for a device, to determine whether the device is in shortage.
Reporting Problems to the FDA
The FDA encourages health care providers to report any supply chain challenges or suspected adverse events experienced with stereotactic breast biopsy needles.

By promptly reporting device availability issues and potential shortages, you can help the FDA understand the scope of the problem, and, when possible, mitigate the issue.
Contact Information
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).
Additional Resources  

ACR Mitigation Strategies for Breast Biopsy Needle Shortage
Hologic Update on Brevera Biopsy Needle Availability
Hologic Update on Eviva Breast Biopsy System

Content current as of:
06/16/2026

Source: US Food and Drug Administration

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Anyone can save a life during an opioid overdose with naloxone, a front-line defense in the nation’s overdose crisis. Naloxone is a life-saving drug that, when sprayed into the nose or injected, quickly reverses the powerful effects of opioids during an overdose.
Everyone who overdoses with opioids, whether with a prescribed medicine or an illicit drug, can use naloxone, including nasal sprays and injections. Examples of opioids include heroin, fentanyl, oxycodone, hydrocodone, codeine, and morphine.
Naloxone products approved by the U.S. Food and Drug Administration are an important tool to reverse overdose in health care and community settings. That’s one of many reasons the FDA is working to help increase access to naloxone. For example, the FDA recently approved the third OTC naloxone nasal spray to reverse the effects of opioid overdose.
“Without the administration of naloxone, there is a high risk of fatality from an opioid overdose,” said Marta Sokolowska, Ph.D., deputy center director for substance use and behavioral health at the FDA. “This is the reason it is very important that anyone witnessing an opioid overdose has access to naloxone and feels confident using it during an emergency.”
How to Recognize an Opioid Overdose and Use Naloxone
Opioids are medications that can be used to treat certain kinds of pain or opioid use disorder. Some illicit or nonprescribed substances such as heroin are also opioids. Signs of an opioid overdose may include:

unconsciousness or unresponsiveness (doesn’t wake up when shaken or called)
shallow breathing
limpness
blue lips, gums, or fingertips
slow or irregular heartbeat or pulse

“Anyone – including family members, caregivers, or other people who may have to use naloxone in an opioid overdose – should be taught to recognize the signs of an opioid overdose and to administer naloxone,” Sokolowska said.
Naloxone is very powerful and works quickly. When administered soon after someone starts experiencing an overdose, the person will usually wake up within one to three minutes. Repeat administration of naloxone may be necessary.
But naloxone is a temporary treatment, and its effects do not last long, thus it is extremely important to still call 911. After giving someone naloxone and calling 911, stay with the person, even if they are conscious, until emergency medical help arrives. The person could lapse back into unconsciousness and might need another dose of naloxone. Keep trying to wake them up and keep them breathing. Also, lay the person on their side to prevent them from choking if they are unconscious.
Discuss Naloxone When Getting a Prescription for Opioids
Some naloxone products are safe and effective for nonprescription (over-the-counter, or OTC) use, while some other products may require a prescription.
Many states allow “standing orders” – that means consumers can get naloxone directly from a pharmacist, without a prescription. This allows access to naloxone to anyone who thinks they might need it, either for themselves or for someone else who might be at risk for an overdose.
“Naloxone should be available to anyone taking opioids and to anyone who may be around people who are taking opioids,” Sokolowska said. “This medicine is safe and very effective. It is also important to know that naloxone is not addictive.”
To reduce the risk of death from opioid overdose, the FDA recommends that these people carry naloxone:

People who are prescribed opioid pain relievers.
People who are prescribed medicines to treat opioid use disorder.
People who are at increased risk of opioid overdose, such as people who also use alcohol or other drugs such as benzodiazepines.
Caregivers of people who are at risk of an opioid overdose.

“We want naloxone in the hands of the friends, family members, and caregivers of people taking opioids,” Sokolowska added.
Naloxone Will Not Harm Someone Who Does Not Have Opioids in Their System
If someone is having a medical emergency other than an opioid overdose – such as a diabetic coma or cardiac arrest – giving them naloxone will generally not have any effect or cause them additional harm.
Naloxone can be administered to people of all ages, so it can also be used for suspected overdose in infants, children, and the elderly.
“Don’t hesitate to administer naloxone in an emergency even if you’re not sure if the person is experiencing an opioid overdose,” Sokolowska said. “Giving someone naloxone who does not have opioids in their system shouldn’t hurt them, but it could help them and save their life.”

Source: US Food and Drug Administration

Summary

Company Announcement Date:
June 11, 2026
FDA Publish Date:
June 12, 2026
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description
Above acceptable microbiological limits for yeast and may contain Aspergillus spp.

Company Name:
Beekeeper’s Naturals
Brand Name:

Brand Name(s)
Beekeeper’s Naturals

Product Description:

Product Description
Saline Nasal Spray

Company Announcement
FOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA – Beekeeper’s Naturals is voluntarily recalling lot # 5950, Exp. Date 02/2028 of Beekeeper’s Naturals Saline Nasal Spray, sold only through Amazon, to the consumer level. This lot, produced at a third-party manufacturer, tested above our acceptable microbiological limits for yeast and may contain Aspergillus spp.
In the population most at risk, such as people with weakened immune systems or lung diseases, there is a reasonable probability that use of the product with Aspergillus spp. contamination will cause serious and life-threatening infections such as invasive sinusitis and lung infections.
To date, Beekeeper’s Naturals has received four reports from customers regarding adverse reactions potentially related to the recalled product, including sinus congestion, irritation or infection. 
Beekeeper’s Naturals Saline Nasal Spray is used as a sinus congestion rinse. The product is sold in a single-unit 1 FL OZ. (30 mL) bottle and the lot number (5950) and expiration date (02/2028) can be found on the bottom or back label.
Five hundred and eighty-five (585) units of this lot 5950 were sold through Amazon between April 2 and April 24, 2026. Due to a clerical error, this lot 5950 was mistakenly shipped to Amazon before testing results became available. Working with Amazon, we have already directly notified all purchasers of this lot 5950 of Beekeeper’s Naturals Saline Nasal Spray.
No other Beekeeper’s Naturals products, including Nasal Spray Max, are impacted by this voluntary recall.
If you think you have this lot of Beekeeper’s Naturals Saline Nasal Spray:

Check the lot number on the bottom or back label of your Beekeeper’s Naturals Saline Nasal Spray
If it reads Lot 5950 (Best By: 02/2028), discontinue use
Contact us at contact@beekeepersnaturals.com or 1-888-759-6910, Monday-Friday 8am to 8pm ET, for a refund, or if you have any other questions.
If you have experienced any problems that may be related to taking or using this product, contact your physician or healthcare provider

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Beekeeper’s Naturals has taken immediate corrective action to identify and resolve the source of the concern. We remain fully committed to the rigorous quality standards our customers expect from us.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Content current as of:
06/12/2026

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