Diclofenac Sodium and Misoprostol Delayed-Release Tablets — Class II drug recall D-817-2013
Terminated recall by Watson Laboratories, Inc.-(Actavis) - Florida, reported 2013-07-31, distributed nationwide. Failed Tablet/Capsule Specifications: Broken tablets
| Recall number | D-817-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Watson Laboratories, Inc.-(Actavis) - Florida, Davie, FL, United States |
| Recall initiated | 2013-03-22 |
| Classified | 2013-07-23 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2014-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 392,400 tablets |
| NDC | 00591-0397, 00591-0397-19, 00591-0397-60, 00591-0398, 00591-0398-60 |
| Lot numbers | 10/14, 635098A |
Product
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
Reason for recall
Failed Tablet/Capsule Specifications: Broken 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-817-2013. 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.