Diclofenac Sodium and Misoprostol Delayed-Release Tablets — Class II drug recall D-0258-2015
Terminated recall by Actavis Laboratories, FL, Inc., reported 2014-12-03, distributed nationwide. Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
| Recall number | D-0258-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis Laboratories, FL, Inc., Davie, FL, United States |
| Recall initiated | 2014-09-26 |
| Classified | 2014-11-21 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 5,451 bottles |
| UPC / GTIN / UDI-DI | 00305910398606 |
| NDC | 00591-0397, 00591-0397-19, 00591-0397-60, 00591-0398, 00591-0398-60 |
| Lot numbers | 694320A |
| Expiration dates | 2015-02-28 |
Product
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC: 0591-0398-60, UPC 3 05910 39860 6.
Reason for recall
Failed Tablet/Capsule Specifications: Presence of split or 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-0258-2015. 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.