# FDA recall D-0745-2026

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2026-08-05.

## Product

Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.

## Reason for recall

CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0745-2026
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-08-05
- **Report date:** 2026-08-12

- **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-0745-2026

## Citation

> AI Analytics. FDA recall D-0745-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/D-0745-2026. Source: US FDA. Licensed CC0.

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