FDA Drug recall D-0868-2026
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured b…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured b… by Amneal Pharmaceuticals, citing defective Delivery System: Possibility of no medication in the prefilled pen.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0868-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-28 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Defective Delivery System: Possibility of no medication in the prefilled pen.
Identifiers
| ndc | 70121-1685-1 |
|---|---|
| ndc | 70121-1686-1 |
| code_info | Lot #: AP250095A, Exp 2/28/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
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All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0868-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.