Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0 — Class II drug recall D-0826-2018
Terminated recall by Exela Pharma Sciences LLC, reported 2018-05-30, distributed nationwide. Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac
| Recall number | D-0826-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exela Pharma Sciences LLC, Lenoir, NC, United States |
| Recall initiated | 2018-04-20 |
| Classified | 2018-05-22 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2020-06-04 |
| Distributed | Nationwide (US) |
| Quantity | 5,256 bottles |
| Reason classes | labeling |
| NDC | 42367-0111-06 |
| Lot numbers | 12/18, GH70154 |
Product
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
Reason for recall
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg 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-0826-2018. 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.