Multi event Drug Recall Enforcement Report Class III voluntary initiated by AvKARE, originally initiated on 06-26-2025 for the product Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90 The product was recalled due to failed impurity/degradation specifications. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0529-2025 | 06-26-2025 | 07-09-2025 | Class III | 8,573 bottles | Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90 | Failed Impurity/Degradation Specifications | Ongoing |
| D-0528-2025 | 06-26-2025 | 07-09-2025 | Class III | 1,560 bottles | Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90 | Failed Impurity/Degradation Specifications | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 42291-905 | Pitavastatin | Pitavastatin Calcium | Tablet, Film Coated | Oral | Avkare | Human Prescription Drug |
| 42291-906 | Pitavastatin | Pitavastatin Calcium | Tablet, Film Coated | Oral | Avkare | Human Prescription Drug |
| 42291-907 | Pitavastatin | Pitavastatin Calcium | Tablet, Film Coated | Oral | Avkare | Human Prescription Drug |
