# FDA recall D-0181-2021

> **CIPLA** · Class II · drug recall initiated 2020-12-17.

## Product

Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34

## Reason for recall

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0181-2021
- **Recalling firm:** CIPLA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-17
- **Report date:** 2021-01-06
- **Termination date:** 2022-12-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warren, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0181-2021

## Citation

> AI Analytics. FDA recall D-0181-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0181-2021. Source: US FDA. Licensed CC0.

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