RemedyRepack Inc. 2025-02-12 Health serious FDA
Health · FDA · Recall #FDA-D-0217-2025
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx… Recall
Issued February 12, 2025 · RemedyRepack Inc.
In February 2025, RemedyRepack Inc. recalled the Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
What you should do
- 1 Stop using Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact RemedyRepack Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- RemedyRepack Inc.
- Category
- Health
- Recall date
- February 12, 2025
- Units affected
- Not reported
- Sold at
- FL
- Recall number
- FDA-D-0217-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- RemedyRepack Inc. has 12 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.