RemedyRepack Carvedilol Tablets Recall: N-Nitroso Impurity Risk
RemedyRepack recalls Carvedilol 25mg tablets due to unsafe N-Nitroso Carvedilol Impurity-1 levels. Affected lots expire May 2025 and July 2025. Stop using immediately if you have these specific lots.
Recall notice
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Contact the company
What happened, in plain English
RemedyRepack is recalling Carvedilol 25 mg tablets that contain an unsafe chemical impurity. This impurity could pose a health risk if taken in amounts exceeding the FDA's safety limits. Read more at govinfonow.com/recall/32319-remedyrepack-carvedilol-tablets-recall-n-nitroso-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32319-remedyrepack-carvedilol-tablets-recall-n-nitroso-impurity-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0217-2025
Cite this page
“RemedyRepack Carvedilol Tablets Recall: N-Nitroso Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32319-remedyrepack-carvedilol-tablets-recall-n-nitroso-impurity-risk. Based on FDA recall #D-0217-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0217-2025%22&limit=1).
Why it’s dangerous
The tablets contain N-Nitroso Carvedilol Impurity-1 (NNC 1) at levels above the FDA's acceptable limit. This impurity could potentially cause health issues if consumed in the amounts that exceed the safe threshold.
Who’s affected
People with prescriptions for Carvedilol 25 mg tablets from the specific lots listed (J0777493050824 and J0787856062124) are affected. Those who have taken these tablets without medical supervision are at risk.
How to tell if you have this one
Check the blister pack for the lot numbers J0777493050824 or J0787856062124. These tablets were manufactured by Glenmark in Mahwah, NJ and repackaged by RemedyRepack in Indiana, PA.
- Brand
RemedyRepack- Category
Drug
What to do — step by step
Stop Using Immediately
If you have the recalled lot numbers, stop using these tablets right away.
Where it went and when
Where it was distributed
Distributed in Florida.
FDA distribution: “FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0217-2025 (January 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0217-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.