# FDA recall D-0159-2026

> **Zydus Pharmaceuticals (USA) Inc** · Class II · drug recall initiated 2025-10-23.

## Product

Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06

## Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0159-2026
- **Recalling firm:** Zydus Pharmaceuticals (USA) Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-23
- **Report date:** 2025-11-26

- **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-0159-2026

## Citation

> AI Analytics. FDA recall D-0159-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0159-2026. Source: US FDA. Licensed CC0.

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