Irbesartan Tablets USP recall — Class II (D-0224-2025) · pharmaranks
Class IIOngoing
Irbesartan Tablets USP recall
FDA recall D-0224-2025 · initiated Jan 21, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Out of Specification for Dissolution
Details
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
Recalling company
AvKARE
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA
Initiated
Jan 21, 2025
FDA report date
Feb 19, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.