Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit
Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 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 FDA's named 4.0 ppm limit, with no injury reported in the source.
Plain-English summary
Carvedilol Tablets, USP, 12.5 mg, 500 tablets per carton, prescription only, manufactured by Glenmark Pharmaceuticals Ltd. of Pithampur, Madhya Pradesh, India for Glenmark Pharmaceuticals, is being recalled. The action covers 17,496 bottles.
The stated reason is CGMP deviations: results for the N-Nitroso Carvedilol Impurity-1 impurity were observed to be above the FDA-recommended limit of not more than 4.0 ppm. The FDA classified the action as Class II.
Affected lots are 17241257, 17241258 and 17241279, expiring 06/2026. Distribution was nationwide within the USA.
Patients holding affected lots 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
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 (4)
- Lot #: 17241257
- 17241258
- 17241279
- Exp. Date 06/2026
UPCs (4)
- 0368462162019
- 0368462163016
- 0368462164013
- 0368462165010
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same brand · CARVEDILOL
- HighMajor Pharmaceuticals carvedilol tablets recalled over nitrosamine impurity above FDA limit
FDA (Drugs) · 2025-08-27
- HighCarvedilol 25 mg tablets recalled over nitrosamine impurity above FDA limit
FDA (Drugs) · 2025-08-20
- HighGlenmark carvedilol 25 mg tablets exceed the acceptable nitrosamine intake level
FDA (Drugs) · 2025-08-20
- HighCarvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit
FDA (Drugs) · 2025-08-20
- HighCarvedilol 12.5 mg tablets recalled over nitrosamine above acceptable intake level
FDA (Drugs) · 2025-08-20
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
Same hazard · nitrosamine
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
FDA (Drugs) · 2026-02-11
- HighClomipramine 25 mg capsules recalled over nitrosamine above the intake limit
FDA (Drugs) · 2025-11-12
Similar recalls
- HighCarvedilol 12.5 mg tablets recalled over nitrosamine above acceptable intake level
FDA (Drugs) · 2025-08-20
- SevereCarvedilol Tablets 12.5 mg Recalled for Impurity Above Limit
FDA (Drugs) · 2025-06-04
- HighGlenmark carvedilol 25 mg tablets exceed the acceptable nitrosamine intake level
FDA (Drugs) · 2025-08-20
- SevereCarvedilol Tablets Recalled Due to N-Nitroso Impurity
FDA (Drugs) · 2025-06-04
- HighCarvedilol 3.125 mg tablets recalled for nitrosamine impurity above intake limit
FDA (Drugs) · 2025-08-20
- SevereCarvedilol Tablets 25 mg Recalled Due to Impurity Above Acceptable Limit
FDA (Drugs) · 2025-06-04