FDA Drug recall D-397-2014
Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only
- FDA Drug
- Class II
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class II recall of Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only by Watson Laboratories, citing presence of Foreign Substance; metal particulates were visually observed in the tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-397-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-23 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Watson Laboratories |
| Distribution | US |
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
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Identifiers
| code_info | Lot # 244152A, exp 01/15. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2013-10-16 · Watson Laboratories - Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc
FDA Drug · Class II · 2013-10-09 · Watson Laboratories - Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocon…
FDA Drug · Class III · 2013-09-25 · Watson Laboratories - Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737…
FDA Drug · Class III · 2013-07-31 · Watson Laboratories
All Watson Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-397-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.