Carisoprodol Tablets — Class II drug recall D-397-2014
Terminated recall by Watson Laboratories Inc, reported 2014-01-15, distributed nationwide. Presence of Foreign Substance; metal particulates were visually observed in the tablets.
| Recall number | D-397-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Watson Laboratories Inc, Corona, CA, United States |
| Recall initiated | 2013-12-23 |
| Classified | 2014-01-06 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2014-08-04 |
| Distributed | Nationwide (US) |
| Quantity | 4,439 bottles |
| Reason classes | specification failure |
| NDC | 00591-5513-05 |
| Lot numbers | 01/15, 244152A |
Product
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.
Reason for recall
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
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-397-2014. 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.