Class II
Ongoing
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
This recall is currently active, issued November 26, 2025. It was issued by Zydus Pharmaceuticals (Usa) Inc.
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- October 23, 2025
- Posted
- November 26, 2025
- Recall Number
- D-0159-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 36,624 bottles
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot #: M313934, M313935, M315615, Exp. Date Nov 2025; M316809 , Exp. Date Dec-25; M405765, M405763, M405764, Exp. Date Apr-26; M414999, M414241, M414307, M414305, Exp. Date Oct-26
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