Carvedilol 25 mg tablets recalled due to N-nitroso impurity above limit
RemedyRepack Inc. is recalling certain Carvedilol 25 mg tablets because testing found N-nitroso Carvedilol Impurity-1 exceeding FDA's acceptable limit due to manufacturing process deviations.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—N-nitroso impurity above acceptable limits—represents a potential risk but no actual harm has been documented. Per the rubric, this meets the criterion for Score 3 (High): 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
RemedyRepack Inc. is recalling certain Carvedilol 25 mg tablets due to Current Good Manufacturing Practice deviations. Testing found N-Nitroso Carvedilol Impurity-1 present at levels above FDA's recommended acceptable intake limit. The recalled product is identified by NDC number 70518-3945-00 and was distributed in 247 blister packs (30 tablets per pack).
The affected lots are: Lot #J0777493050824 (expires 5/31/2025) and Lot #J0787856062124 (expires 7/31/2025).
Patients who have this medication should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC: 70518-3945-00.
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Cardiovascular
- Hazard
- n-nitroso-impurity
- manufacturing-defect
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 #s: J0777493050824
- Exp. 5/31/2025
- J0787856062124
- Exp. 7/31/2025.
Distribution
Distributed in 1 state:
- FL
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