Amneal Pharmaceuticals of New York recall: Exenatide Injection
Amneal Pharmaceuticals of New York, LLC is recalling Exenatide Injection – 5,694 pens. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on August 28, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Exenatide Injection |
| Brand | Amneal Pharmaceuticals of New York |
| Company | Amneal Pharmaceuticals of New York, LLC |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 28, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 5,694 pens |
| Recall ID | 99762 |
Recalled products
- 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
- FDA recall number
- D-0868-2026
- Codes, lots and dates
- Lot #: AP250095A, Exp 2/28/2027
- Quantity
- 5,694 pens
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99762
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Brookhaven, NY, United States
Why it was recalled
The reason the FDA lists: “Defective Delivery System: Possibility of no medication in the prefilled pen.”
Where it was sold
Nationwide. Distribution as the FDA records it: “USA Nationwide”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99762, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Amneal Pharmaceuticals of New York Exenatide Injection recalled?
Yes. Amneal Pharmaceuticals of New York, LLC recalled it on August 28, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Defective Delivery System: Possibility of no medication in the prefilled pen.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.