traMADol Hydrochloride Tablets — Class II drug recall D-0408-2026
Ongoing recall by Amneal Pharmaceuticals, LLC, reported 2026-04-08, distributed nationwide. Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of t
| Recall number | D-0408-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amneal Pharmaceuticals, LLC, Bridgewater, NJ, United States |
| Recall initiated | 2026-03-19 |
| Classified | 2026-03-30 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 29,542 bottles |
| Reason classes | specification failure |
| NDC | 60219-2348-05 |
| Lot numbers | AM230987, AR232387 |
| Expiration dates | 2026-05, 2026-12 |
Product
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0408-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.