Irbesartan Tablets USP — Class II drug recall D-0224-2025
Ongoing recall by AvKARE, reported 2025-02-19, distributed nationwide. Out of Specification for Dissolution
| Recall number | D-0224-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2025-01-21 |
| Classified | 2025-02-11 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 341 cartons |
| Reason classes | specification failure |
| NDC | 50268-0442-15 |
| Lot numbers | 45279 |
| Expiration dates | 2025-03-31 |
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 for recall
Out of Specification for Dissolution
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0224-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.