Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Recalls
- Oct 23, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Lots: 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 - May 9, 2016 · Class II · Zydus Pharmaceuticals USA Inc
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.
Lots: Lot # MP993, Exp10/16; MR2704, Exp 02/17; MR6851, MR8100; Exp 07/17 and MR1210, Exp 12/17
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bromocriptine: every company that makes it
- Form
- capsule, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA078899
- On the market since
- Jan 23, 2009
- Package NDCs
68382-110-0168382-110-06- Official label
- DailyMed (National Library of Medicine), updated Jul 28, 2026
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