Irbesartan Tablets USP recall
FDA recall D-0224-2025 · initiated Jan 21, 2025
AvKARE recalled Irbesartan Tablets USP in Jan 2025 — an FDA Class II recall (D-0224-2025) because Out of Specification for Dissolution.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Out of Specification for Dissolution
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 341 cartons
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
Frequently asked
- Was Irbesartan Tablets USP recalled?
- AvKARE recalled Irbesartan Tablets USP in Jan 2025 — an FDA Class II recall (D-0224-2025) because Out of Specification for Dissolution. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Irbesartan Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0224-2025 was: Out of Specification for Dissolution
- Is a recalled Irbesartan Tablets USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Irbesartan Tablets USP are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot 45279, Exp 03/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0224-2025.