Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90

FDA recall notice · announced July 9, 2025 · Avkare

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
Quantity: 1,560 bottles
Status: Ongoing
Products in this recall event:
- Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90 (D-0529-2025)
- Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90 (D-0528-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.