Carvedilol Tablets 6.25 mg Recalled for N-Nitroso Impurity
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit. The recall affects 100-count and 500-count bottles distributed nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II drug recall with identified manufacturing deviations (CGMP) and presence of a nitrosamine impurity (N-Nitroso Carvedilol I) above acceptable intake limits, meeting the criterion for Severe classification.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 6.25 mg in 100-count bottles (NDC 68462-163-01) and 500-count bottles (NDC 68462-163-05). The recall was initiated due to current Good Manufacturing Practice (CGMP) deviations and the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit.
Affected lot numbers and expiration dates for 100-count bottles include: Lot 19231618 (Mar-25), 19232064 (Apr-25), 19232324 (May-25), 19233369 (Jul-25), 19234162 (Sep-25), and 19240543 (Jan-26). Affected lot numbers for 500-count bottles include: Lots 19231174, 19231199, 19231164 (Feb-25); 19231517, 19231527, 19231566, 19231568, 19231595, 19231618, 19231634, 19231638, 19231448 (Mar-25); 19232043, 19232051, 19232064 (Apr-25); 19232322, 19232324, 19232365, 19232380, 19232389 (May-25); 19232736, 19232743, 19232746, 19232756, 19232757 (Jun-25); 19233369, 19233371, 19233405, 19233416 (Jul-25); 19234162, 19234183, 19234192, 19234204, 19234223, 19234243, 19234263, 19234165, 19234242 (Sep-25); 19234743, 19234774, 19234993 (Nov-25); 19240223, 19240203, 19240211, 19240214, 19240247, 19240249, 19240272, 19240319 (Dec-25); and 19240543 (Jan-26). The affected product has been distributed U.S. nationwide.
Patients taking the affected medication should consult their healthcare provider before stopping the medication or for guidance on obtaining a replacement. Healthcare providers and pharmacists should stop dispensing affected lots immediately.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
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 (20)
- [100-Count Bottles] Lot 19231618
- exp Mar-25
- 19232064
- exp Apr-25
- 19232324
- May-25
- 19233369
- Exp Jul-25
- Lot 19234162
- Exp Sep-25
- Lot 19240543
- Exp Jan-26 [500-Count Bottles] Lots 19231174
- 19231199
- 19231164
- Exp Feb-25
- 19231517
- 19231527
- 19231566
- 19231568
- 19231595
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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.
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