WhichRecall
Class IIReported 2025-11-26

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

Recalled by Zydus Pharmaceuticals (USA) Inc

Reason for Recall

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

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Recall Number
D-0159-2026
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-10-23
Reported
2025-11-26
Distribution
Nationwide in the USA
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
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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