Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bromocriptine Mesylate Capsules USP Recalled by Zydus Pharmaceuticals USA Inc Due to Failed impurities/degradation specifications: Out of specification results noticed...
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-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06
Quantity: 14,808 bottles
Why Was This Recalled?
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zydus Pharmaceuticals USA Inc
Zydus Pharmaceuticals USA Inc has 41 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report