# FDA recall D-0826-2018

> **Exela Pharma Sciences LLC** · Class II · drug recall initiated 2018-04-20.

## 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.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0826-2018
- **Recalling firm:** Exela Pharma Sciences LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-20
- **Report date:** 2018-05-30
- **Termination date:** 2020-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lenoir, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0826-2018

## Citation

> AI Analytics. FDA recall D-0826-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0826-2018. Source: US FDA. Licensed CC0.

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