FDAFDA · Food and drugs·Recall number D-0159-2026
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
Published November 26, 2025 · Recall initiated: October 23, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BROMOCRIPTINE MESYLATE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide in the USA
- UPC
- 0368382110015
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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