Amneal Pharmaceuticals, LLC 2026-04-08 Health serious FDA
Health · FDA · Recall #FDA-D-0408-2026
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by:… Recall
Issued April 8, 2026 · Amneal Pharmaceuticals, LLC
In April 2026, Amneal Pharmaceuticals, LLC recalled the traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by:…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
What you should do
- 1 Stop using traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Amneal Pharmaceuticals, LLC 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
- Amneal Pharmaceuticals, LLC
- Category
- Health
- Recall date
- April 8, 2026
- Units affected
- Not reported
- Sold at
- Nationwide within the USA
- Recall number
- FDA-D-0408-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Amneal Pharmaceuticals, LLC has 6 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.