Drug Recall: 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. ND
Zydus Pharmaceuticals (USA) Inc · October 23, 2025
Reason for Recall
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Product Description
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
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
36,624 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0159-2026
Status: ongoing
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