# FDA recall D-1491-2016

> **Zydus Pharmaceuticals USA Inc** · Class II · drug recall initiated 2016-05-09.

## Product

Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06

## Reason for recall

Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.

## Distribution

US Nationwide

## Key facts

- **Recall number:** D-1491-2016
- **Recalling firm:** Zydus Pharmaceuticals USA Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-05-09
- **Report date:** 2016-09-14
- **Termination date:** 2018-05-01

- **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-1491-2016

## Citation

> AI Analytics. FDA recall D-1491-2016. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-1491-2016. Source: US FDA. Licensed CC0.

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