Rosuvastatin Tablets — Class II drug recall D-0292-2026
Ongoing recall by AvKARE, reported 2026-01-14, distributed nationwide. Out of specification for dissolution.
| Recall number | D-0292-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2025-12-31 |
| Classified | 2026-01-20 |
| Reported by FDA | 2026-01-14 |
| Distributed | Nationwide (US) |
| Quantity | 7,991 |
| Reason classes | specification failure |
| NDC | 50268-0709, 50268-0709-11, 50268-0709-15, 50268-0710, 50268-0710-11, 50268-0710-15, 50268-0711, 50268-0711-11, 50268-0711-15 |
| Lot numbers | 49124 |
| Expiration dates | 2026-12-31 |
Product
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
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-0292-2026. 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.