Ergot Derivative
Where is Bromocriptine made?
9 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 4 factories in the United States, Italy and India.
United States 2Italy 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Avvisto Therapeutics LLC Cycloset0.8 mg · NDC 73515-123 | Curia Italy S.r.l.Makes the active ingredient | Rozzano, Italy | Problems found, fixed voluntarilySep 2022 |
| Patheon Pharmaceuticals Inc.Makes it | Cincinnati, OH, United States | Problems found, fixed voluntarilySep 2025 | |
| Cadila Healthcare Limited5 mg · NDC 65841-654 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Caraco Pharmaceutical Laboratories, Ltd. Bromocriptine Mesylate2.5 mg, 5 mg · NDC 63304-962, 63304-158 | Halo Pharmaceutical IncMakes it | Whippany, NJ, United States | No problems foundDec 2025 |
| Zydus Pharmaceuticals (USA) Inc.5 mg · NDC 68382-110 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| ANI Pharmaceuticals, Inc. Bromocriptine Mesylate2.5 mg, 5 mg · NDC 70954-978, 70954-951 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.5 mg · NDC 0378-7096 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC2.5 mg · NDC 0574-0106 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.2.5 mg · NDC 0781-5325 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Validus Pharmaceuticals LLC Parlodel2.5 mg, 5 mg · NDC 30698-202, 30698-201 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Bromocriptine in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- American Health Packaging:
60687-931 - Carilion Materials Management:
68151-1305 - Physicians Total Care, Inc.:
54868-5667 - Remedyrepack Inc.:
70518-4628
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. - 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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.