American Regent Recalls Epinephrine Injection Vials Over Particles And Sterility Concerns

(MENAFN- Grocery Coupon Guide) American Regent is recalling three lots of Epinephrine Injection, USP after complaints involving cracked and leaking vials and an investigation that found particulate matter in the medication.

The voluntary nationwide recall applies to Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) multidose vials and extends to the consumer level. The company announced the recall September 3, 2026, according to a notice posted by the U.S. Food and Drug Administration.

Three Lots of Epinephrine Injection Are Affected

All of the recalled vials carry NDC 0517-3030-01, but consumers and healthcare providers should also check the lot number and expiration date.

The affected products are:

Lot 25128L1C0 - expires August 2026 Lot 25280L1C0 - expires October 2026 Lot 26108L1C0 - expires July 2027

The lots were distributed nationwide between September 2025 and July 2026, although the exact distribution period differs by lot.

This recall involves 30 mL multidose vials of injectable epinephrine. It should not be confused with a recall of consumer epinephrine auto-injectors such as EpiPens.

Cracked Vials and Particles Could Pose Serious Risks

According to the FDA recall announcement, American Regent received customer complaints involving leaking and cracked vials, raising concerns that the containers may no longer maintain sterility.

The company's investigation also identified particulate matter consisting of nylon, cellulosic material, acrylic, polyethylene, and glass.

The company warned that intravenous administration of medication containing particulate matter could cause blockages or clotting in blood vessels. Potential consequences include reduced blood flow to vital organs, pulmonary embolism, permanent organ damage, or death.

Particles may also cause vein irritation, inflammatory reactions, aggravate existing infections, or trigger allergic reactions. Cracked containers introduce an additional concern because a loss of container integrity can allow contamination of what is intended to be a sterile injectable medication.

American Regent said it had received no reports of adverse events associated with the recall as of September 3.

Epinephrine Is Used in Medical Emergencies

Epinephrine Injection, USP is used for the emergency treatment of severe Type I allergic reactions, including anaphylaxis caused by foods, medications, insect stings or bites, and other allergens. It can also be used to increase blood pressure in adults experiencing hypotension associated with septic shock.

The recalled product is a clear, colorless sterile solution packaged in 30 mL multidose vials containing 1 mg of epinephrine per milliliter. It may be administered intravenously, intramuscularly, or subcutaneously and is intended to be used by or under the direction of a physician.

Because epinephrine may be needed in life-threatening situations, healthcare facilities should identify affected inventory rather than simply assuming all American Regent epinephrine products are included in the recall.

What to Do If You Have a Recalled Vial

American Regent is notifying distributors and customers and arranging for the return or replacement of recalled products.

Distributors, retailers, and healthcare facilities with affected inventory should stop using the recalled product and return it to the place of purchase or discard it according to the company's instructions. Patients using an affected product are instructed to stop using it and contact their doctor or other healthcare provider.

American Regent Customer Service can be reached at 800-645-1706 Monday through Thursday from 8 a.m. to 6 p.m. Eastern and Friday from 8 a.m. to 4 p.m. Eastern for information about returns, replacements, and credits.

Product-quality complaints can be reported at 888-354-4855, while adverse events can be reported to American Regent Pharmacovigilance at 800-734-9236.

Patients or healthcare professionals who believe an adverse reaction or product-quality problem may be associated with the recalled medication can also report it through the FDA's MedWatch program.

Anyone checking inventory should match the NDC, lot number, and expiration date rather than relying only on the medication name or manufacturer. Other lots of American Regent Epinephrine Injection are not identified in this September 3 recall.

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