Bromocriptine capsules recalled after an out of specification impurity result
Zydus Pharmaceuticals is recalling 36,624 bottles of Bromocriptine Mesylate Capsules USP 5 mg after an out of specification result for the 2-Bromoergine impurity.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 as a specification failure: the record reports an out of specification impurity result without citing an exceeded safety limit or a health consequence.
Plain-English summary
Bromocriptine Mesylate Capsules, USP, 5 mg, in 30-capsule bottles, manufactured by Zydus Lifesciences of Ahmedabad, India and distributed by Zydus Pharmaceuticals of Pennington, New Jersey, NDC 68382-110-06, are being recalled for failed impurities and degradation specifications.
An out of specification result was reported for the 2-Bromoergine impurity.
The recall covers 36,624 bottles across lots including M313934, M313935 and M315615 (expiring November 2025), M316809 (December 2025) and M405765, M405763 and M405764. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record names the impurity specification failure without describing a health consequence, and reports no injuries. This is a prescription medicine, so patients holding an affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
- Brand
- BROMOCRIPTINE MESYLATE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Dopamine agonist
- Affected units
- 36,624
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
UPCs (1)
- 0368382110015
Distribution
Distributed nationwide across the United States.
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