FDA Recall D-0528-2025

AvKARE · Pulaski, TN

Class III Ongoing 322 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

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

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

Quantity: 1,560 bottles

Reason for recall

Failed Impurity/Degradation Specifications

Recall record

Recall number: D-0528-2025
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-06-26
Classified by FDA Center: 2025-07-16
FDA published: 2025-07-09
Recalling firm: AvKARE
Firm location: Pulaski, TN

Drug identification

Brand name(s): PITAVASTATIN
Generic name(s): PITAVASTATIN CALCIUM
Manufacturer(s): AvKARE
NDC(s): 42291-905, 42291-906, 42291-907
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls