FDA Drugs recall ·

Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only… recall

Recall number
D-0529-2025
Date
(initiated June 26, 2025)
Company / brand
AvKARE
615 N 1st St, Pulaski, TN, United States
Category
Drugs › Class III
Classification
Class III
Status
Ongoing
Units affected
8,573 bottles
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90

Why was it recalled?

Failed Impurity/Degradation Specifications

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026

Distribution

Nationwide in the USA

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (drugs), recall D-0529-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.