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Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN...

FDA Recall #D-0528-2025 — Class III — June 26, 2025

Recall #D-0528-2025 Date: June 26, 2025 Classification: Class III Status: Ongoing

Product Description

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

Recalling Firm

AvKARE — Pulaski, TN

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

1,560 bottles

Distribution

Nationwide in the USA

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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