Carvedilol Tablets recall
FDA recall D-0577-2025 · initiated Aug 7, 2025
Glenmark Pharmaceuticals Inc., USA recalled Carvedilol Tablets in Aug 2025 — an FDA Class II recall (D-0577-2025) because CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
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: 44,328 bottles
Details
- Product
- Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 7, 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-0577-2025) because CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level. 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-0577-2025 was: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- 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 in the USA. The recall covers these lots — Lot#: a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026. 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-0577-2025.