Reported Nov 26, 2025 · Ongoing
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd.,…
Zydus Pharmaceuticals (USA) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only
- Manufactured byZydus Lifesciences Ltd., Ahmedabad, India
- Distributed byZydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
- Lot codes and dates
Lot #: M313934M313935M315615Exp. Date Nov 2025M316809Exp. Date Dec-25M405765M405763M405764Exp. Date Apr-26M414999M414241M414307M414305Exp. Date Oct-26
- Amount recalled
- 36,624 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
This product could cause temporary or reversible health problems — stop using it.
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