FDA Drugs recall ·
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton… recall
Read the official FDA notice ↗
Product
Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15
Why was it recalled?
Out of Specification for Dissolution
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 45279, Exp 03/31/2025
Distribution
Nationwide in the USA
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-0224-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.