United StatesBromocriptine Mesylate Capsules, USP 5 mg, 30‑count prescription bottles (NDC 68382‑110‑06) manufactured by Zydus Lifesciences Ltd. and distributed by Zydus Pharmaceuticals (Pennington, NJ) are being recalled; affected lots are M313934, M313935, M315615 (exp Nov 2025); M316809 (exp Dec 2025); M405765, M405763, M405764 (exp Apr 2026); and M414999, M414241, M414307, M414305 (exp Oct 2026). The recall was initiated due to an out‑of‑specification result for the 2‑bromoergine impurity.
What's being recalled
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
Recalling firm: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States.
How to identify it
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
The hazard
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)