FDA Drugs recall ·
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only… recall
Read the official FDA notice ↗
Product
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
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 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
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-0528-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.