Carvedilol 25 mg Tablet recall
FDA recall D-0217-2025 · initiated Jan 24, 2025
RemedyRepack Inc. recalled Carvedilol 25 mg Tablet in Jan 2025 — an FDA Class II recall (D-0217-2025) because CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 247 blister packs
Details
- 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.
- Recalling company
- RemedyRepack Inc.
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- FL
- Initiated
- Jan 24, 2025
- FDA report date
- Feb 12, 2025
Frequently asked
- Was Carvedilol 25 mg Tablet recalled?
- RemedyRepack Inc. recalled Carvedilol 25 mg Tablet in Jan 2025 — an FDA Class II recall (D-0217-2025) because CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Carvedilol 25 mg Tablet recalled?
- Per the FDA enforcement record, the reason for recall D-0217-2025 was: CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
- Is a recalled Carvedilol 25 mg Tablet dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Carvedilol 25 mg Tablet are affected?
- Distributed: FL. The recall covers these lots — Lot #s: J0777493050824, Exp. 5/31/2025; J0787856062124, Exp. 7/31/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0217-2025.