Bromocriptine Mesylate recalls

Bromocriptine Mesylate products have been recalled 2 times, most recently on 26 Nov 2025. The recalling company is usually Zydus Pharmaceuticals USA. The most common reason is potency & assay.

Total recalls2since 2016

Last 12 months1reported

Class I00% of total

Ongoing1latest 26 Nov 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 1 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why bromocriptine mesylate is recalled

Potency & Assay2100%

Companies

Zydus Pharmaceuticals USA2100%

By year

2025150%
2016150%

Ongoing bromocriptine mesylate recalls

1 active

Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Drug	CLASS II	Bromocriptine Mesylate Capsules, USP, 5 mg recalledBromocriptine Mesylate	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide

All bromocriptine mesylate recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
26 Nov 2025Drug	CLASS II	Bromocriptine Mesylate Capsules, USP, 5 mg recalledBromocriptine Mesylate	Zydus Pharmaceuticals (USA)	Potency & Assay	Nationwide
14 Sep 2016Drug	CLASS II	Bromocriptine Mesylate Capsules USP, 5 mg recalledBromocriptine Mesylate	Zydus Pharmaceuticals USA	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.