FDA Drug recall D-0224-2025
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478
- FDA Drug
- Class II
- ongoing
- Published 2025-02-19
On 2025-02-19 the FDA classified a Class II recall of Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478 by Avkare, citing out of Specification for Dissolution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0224-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-21 |
| Published | 2025-02-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Reason
Out of Specification for Dissolution
Identifiers
| ndc | 50268-440-11 |
|---|---|
| ndc | 50268-440-15 |
| ndc | 50268-441-11 |
| ndc | 50268-441-15 |
| ndc | 50268-442-11 |
| ndc | 50268-442-15 |
| code_info | Lot 45279, Exp 03/31/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0224-2025%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.