CLASS II ONGOING Drug recall · Reported 30 Sep 2026 · FDA Enforcement Report
Exenatide Injection, USP, 250 mcg/mL per prefilled pen recalled
Amneal Pharmaceuticals of New York is recalling Exenatide Injection, USP, 250 mcg/mL per prefilled pen, distributed nationwide in the US. The recall was initiated on 28 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0868-2026
- FDA event ID
- 99762
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Brand
- Exenatide
- Manufacturer
- Amneal Pharmaceuticals LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Aug 2026
- FDA classified
- 22 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Aug 2026 | Recall initiated by company | |
| 22 Sep 2026 | Classified by FDA | +25 days |
| 30 Sep 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System: Possibility of no medication in the prefilled pen.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Defective Delivery System: Possibility of no medication in the prefilled pen.
Which lots are affected?
Lot #: AP250095A, Exp 2/28/2027
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amneal Pharmaceuticals of New York
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylergonovine Maleate Tablets, USP, 0.2mg recalledMethylergonovine Maleate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
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| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenoxybenzamine Hydrochloride Capsules, USP 10mg recalled | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |