Carvedilol Tablets recall
FDA recall D-0588-2025 · initiated Aug 6, 2025
Glenmark Pharmaceuticals Inc., USA recalled Carvedilol Tablets in Aug 2025 — an FDA Class II recall (D-0588-2025) because CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
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: 14,976 bottles
Details
- Product
- Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the USA
- Initiated
- Aug 6, 2025
- FDA report date
- Aug 20, 2025
Frequently asked
- Was Carvedilol Tablets recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Carvedilol Tablets in Aug 2025 — an FDA Class II recall (D-0588-2025) because CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Carvedilol Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0588-2025 was: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- Is a recalled Carvedilol Tablets 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 Carvedilol Tablets are affected?
- Distributed: Nationwide within the USA. The recall covers these lots — Lot #: 17241213, 17241215, 17241224, Exp. Date 06/2026. 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-0588-2025.