Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled… was recalled on August 28, 2026 in cooperation with the U.S. Food and Drug Administration because defective Delivery System: Possibility of no medication in the prefilled pen..
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1685-1
Lot #: AP250095A, Exp 2/28/2027
Units affected: 5,694 pens
Where it was sold: USA Nationwide
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Defective Delivery System: Possibility of no medication in the prefilled pen.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Amneal Pharmaceuticals of New York, LLC
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed dissolution specifications.
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