Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01) recall
FDA recall D-0448-2025 · initiated Feb 28, 2025
Glenmark Pharmaceuticals Inc., USA recalled Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01) in Feb 2025 — an FDA Class II recall (D-0448-2025) because CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
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: [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles
Details
- Product
- Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Feb 28, 2025
- FDA report date
- Jun 4, 2025
Frequently asked
- Was Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01) recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01) in Feb 2025 — an FDA Class II recall (D-0448-2025) because CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01) recalled?
- Per the FDA enforcement record, the reason for recall D-0448-2025 was: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Is a recalled Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01) 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 USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01) are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — [100-Count Bottles] Lot 19231450, Exp Mar-25, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lot 19240280, Exp DEC-25 [500-Count Bottles] Lot 19231450, 19231464, 19231471, 19231493, Exp Mar-25, 19232083, 19232103 Exp Apr-25, 19232658, Exp Jun-25; Lot 19233328, 19233343, 19233344, 19233345, Exp Jul-25; Lot 19234275, Ex…. 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-0448-2025.