[pending] BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
Pending LLM rewrite. Source: FDA_DRUG D-0159-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
The recalled product
- Product
- BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
- Brand
- BROMOCRIPTINE MESYLATE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Drugs
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
Distribution
Distributed nationwide across the United States.
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