Pitavastatin Tablets — Class III drug recall D-0528-2025
Ongoing recall by AvKARE, reported 2025-07-09, distributed nationwide. Failed Impurity/Degradation Specifications
| Recall number | D-0528-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2025-06-26 |
| Classified | 2025-07-16 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 1,560 bottles |
| Reason classes | specification failure |
| NDC | 42291-0905, 42291-0905-90, 42291-0906, 42291-0906-90, 42291-0907, 42291-0907-90 |
| Lot numbers | 46208, 46943, 47738 |
| Expiration dates | 2025-10-31, 2026-05-31, 2026-09-30 |
Product
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Reason for recall
Failed Impurity/Degradation Specifications
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-0528-2025. 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.