Zydus Pharmaceuticals (USA) Inc recalls Bromocriptine Mesylate Capsules
- Recalling company
- Zydus Pharmaceuticals (USA) Inc
- Product
- 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
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 23, 2025
- Reported
- Nov 26, 2025
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 36,624 bottles
- Lot / codes
- 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
- Company location
- Pennington, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0159-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0159-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.