# FDA recall D-0102-2025

> **Zydus Pharmaceuticals (USA) Inc** · Class III · drug recall initiated 2024-11-14.

## Product

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94.  Packaged in sachets

## Reason for recall

Labeling: Not Elsewhere Classified - Wrong NDC number

## Distribution

USA Nationwide.

## Key facts

- **Recall number:** D-0102-2025
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-11-14
- **Report date:** 2024-12-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0102-2025

## Citation

> AI Analytics. FDA recall D-0102-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0102-2025. Source: US FDA. Licensed CC0.

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