Glenmark carvedilol 25 mg tablets exceed the acceptable nitrosamine intake level
Carvedilol Tablets USP 25 mg from Glenmark are being recalled because of the presence of a nitrosamine, N-Nitroso Carvedilol I, above the current Acceptable Intake Level. 4,800 bottles affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a nitrosamine impurity measured above the named Acceptable Intake Level, with no injury reported in the source.
Plain-English summary
Carvedilol Tablets, USP, 25 mg, 500-count bottles, prescription only, manufactured by Glenmark Pharmaceuticals Ltd of Colvale-Bardez, Goa, India for Glenmark Pharmaceuticals, Inc. USA of Mahwah, New Jersey, NDC 68462-165-05, are being recalled. The action covers 4,800 bottles.
The stated reason is CGMP deviations: the presence of a nitrosamine, N-Nitroso Carvedilol I impurity, above the current Acceptable Intake Level. The FDA classified the action as Class II.
The affected lot is 19243104, expiring 7/31/2026. Distribution was nationwide in the USA.
Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by Glenmark.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Oral tablet
- Affected units
- 4,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#:19243104
- Expires: 7/31/2026.
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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