CLASS II Drug recall · Reported 12 Feb 2025 · FDA Enforcement Report
Carvedilol, QTY: per Blister Pack ( blister cards) recalled
RemedyRepack is recalling Carvedilol, QTY: per Blister Pack ( blister cards), distributed in Florida. The recall was initiated on 24 Jan 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0217-2025
- FDA event ID
- 96191
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2025
- FDA classified
- 3 Feb 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 24 Jan 2025 | Recall initiated by company | |
| 3 Feb 2025 | Classified by FDA | +10 days |
| 12 Feb 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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.
Where it was distributed
FL
Questions about this recall
Why was it recalled?
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Which lots are affected?
Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.
Where was it sold?
FL
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from RemedyRepack
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Potassium Chloride Micro 10mEq recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |
| Drug | CLASS II | Phenazopyridine HCl, 100mg tablets recalled by RemedyRepack | RemedyRepack | Packaging Defects | PA |