FDAHealthOctober 23, 2025

Zydus Pharmaceuticals (USA) Inc — Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmac

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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: October 23, 2025

Nationwide in the USA

What's affected?

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
Brand: BROMOCRIPTINE MESYLATE
Lot code: M313934

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 36,624 bottles.

View original FDA notice →

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