Carvedilol tablets recalled due to manufacturing deviation and nitrosamine impurity
Glenmark Pharmaceuticals recalls Carvedilol 12.5 mg tablets nationwide due to presence of N-Nitroso Carvedilol I impurity above acceptable limits and manufacturing deviations. Affected patients should consult their physician.
What this means for you
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: FDA Class II recall involving N-Nitroso impurity, a known chemical contaminant with toxicological concerns, above the recommended acceptable intake limit. No illnesses or injuries reported; the hazard represents a risk-of-harm situation with theoretical potential harm but no documented actual injury.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Carvedilol 12.5 mg tablets in 500-count bottles due to manufacturing deviations and the presence of N-Nitroso Carvedilol I impurity in excess of the FDA-recommended acceptable intake limit.
The recall affects 84,048 bottles distributed nationwide in the United States. Affected lots with April 2025 expiration dates include 19231899, 19231922, 19231927, 19231967, 19231979. May 2025 expiration lots include 19232226, 19232234, 19232265. June 2025 expiration lots include 19232758, 19232759, 19232762, 19232788.
N-Nitroso impurities are chemical contaminants with potential toxicological concerns. While no illnesses or injuries have been reported to date, the presence of this impurity above acceptable limits prompted the voluntary recall to ensure consumer safety.
Patients taking Carvedilol from affected lots should contact their pharmacist or physician to determine if their supply is affected and whether to continue taking their medication. Patients should not stop taking their medication without consulting their healthcare provider.
The recalled product
- Product
- CARVEDILOL (CARVEDILOL)
- Brand
- CARVEDILOL
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- n-nitroso-impurity
- 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.
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