Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bromocriptine Mesylate Capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Impurities/Degradation Specifications: Out of Specification (OOS) result...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zydus Pharmaceuticals (USA) Inc directly.
Affected Products
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
Quantity: 36,624 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zydus Pharmaceuticals (USA) Inc
Zydus Pharmaceuticals (USA) Inc has 51 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report