traMADOL Hydrochloride Tablets — Class II drug recall D-089-2013
Terminated recall by Caraco Pharmaceutical Laboratories, Ltd., reported 2012-12-12, distributed nationwide. Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Table
| Recall number | D-089-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI, United States |
| Recall initiated | 2012-11-05 |
| Classified | 2012-12-06 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2013-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,264 bottles |
| NDC | 57664-0377-18 |
| Lot numbers | 09/13, GKK1373 |
Product
traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.
Reason for recall
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
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-089-2013. 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.