FDA Drugs recall ·
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only… recall
Read the official FDA notice ↗
Product
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
Why was it recalled?
Failed dissolution specifications: lower than 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#: AVC24035, Exp 03/31/26
Distribution
U.S.A. nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0306-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.