FDA Drugs recall ·
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister… recall
- Recall number
- D-0217-2025
- Date
- (initiated January 24, 2025)
- Company / brand
- RemedyRepack Inc.
625 Kolter Dr Ste 4, Indiana, PA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 247 blister packs
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
Distribution
FL
States: Florida
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0217-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.