Carvedilol Tablets 12.5 mg Recalled for Impurity Above Limit
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 12.5 mg due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit, resulting from current Good Manufacturing Practice (CGMP) deviations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class II. The presence of an impurity above the recommended acceptable intake limit in a prescription cardiovascular medication, combined with CGMP deviations, represents a significant quality and safety issue that meets the Severe severity threshold.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol Tablets USP 12.5 mg in 500-count bottles distributed nationwide. The recall is due to the presence of N-Nitroso Carvedilol I impurity above the recommended acceptable intake limit and CGMP deviations.
The affected product is Carvedilol Tablets USP 12.5 mg, NDC 68462-164-05, with the following lot numbers and expiration dates: Lots 19231899, 19231922, 19231927, 19231967, 19231979 (Exp Apr-25); Lots 19232226, 19232234, 19232265, 19232271 (Exp May-25); Lots 19232758, 19232759, 19232762, 19232788 (Exp Jun-25). A total of 84,048 bottles have been distributed in the U.S.
Patients currently taking this medication should consult their healthcare provider before taking any action. Healthcare providers and patients should contact Glenmark Pharmaceuticals Inc., USA for further information regarding this recall.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- impurity-n-nitroso
- cgmp-deviation
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 (17)
- Lot
- Exp: Lots 19231899
- 19231922
- 19231927
- 19231967
- 19231979
- Exp Apr-25
- Lots 19232226
- 19232234
- 19232265
- 1923227
- 1 Exp May-25
- Lots 19232758
- 19232759
- 19232762
- 19232788
- Exp Jun-25
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CARVEDILOL
- SevereCarvedilol Tablets 6.25 mg Recalled for N-Nitroso Impurity
FDA (Drugs) · 2025-06-04
- SevereCarvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit
FDA (Drugs) · 2025-06-04
- SevereCarvedilol Tablets Recalled Due to N-Nitroso Impurity
FDA (Drugs) · 2025-06-04
- ModerateCarvedilol Tablets Recalled Due to CGMP Manufacturing Deviations
FDA (Drugs) · 2025-04-16
- HighCarvedilol Tablets Recalled for Carcinogenic N-Nitroso Impurity Manufacturing Defect
FDA (Drugs) · 2025-02-12
Same category
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateClinere Ear Wax Remover Recalled for Subpotent Carbamide Peroxide
FDA (Drugs) · 2026-07-22