FDA Drug recall D-0529-2025
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478
- FDA Drug
- Class III
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class III recall of Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478 by Avkare, citing failed Impurity/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0529-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-06-26 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Reason
Failed Impurity/Degradation Specifications
Identifiers
| ndc | 42291-906-90 |
|---|---|
| ndc | 42291-907-90 |
| ndc | 42291-905-90 |
| code_info | Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026 |
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-0529-2025%22
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