Recall
FDAHealthJune 26, 2025

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

⚠️ Failed Impurity/Degradation Specifications

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 26, 2025

Nationwide in the USA

What's affected?

Product
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Lot code
46208

Additional details

Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;

What should I do?

Recommended action

Class III recall. Voluntary: Firm initiated Quantity affected: 1,560 bottles.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.