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

FDA recall notice · announced November 26, 2025 · Zydus Pharmaceuticals (usa)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide in the USA
Lot/code information: 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
Quantity: 36,624 bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0159-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.