Zydus Pharmaceuticals (USA) recalls
Zydus Pharmaceuticals (USA) has 95 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 12 Aug 2026. 35 are still ongoing. 14 were reported in the last 12 months. The most frequent reason is potency & assay.
Total recalls95since 2012
Last 12 months14reported
Class I33% of total
Ongoing35latest 12 Aug 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 3 3%Class II 77 81%Class III 15 16%
Why zydus pharmaceuticals (usa) is recalled
Product types
Brands
By year
Ongoing zydus pharmaceuticals (usa) recalls
35 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals (USA) | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
| Drug | CLASS III | traZODONE Hydrochloride Tablets, USP, 100mg recalledTrazodone Hydrochloride | Zydus Pharmaceuticals (USA) | Other | Nationwide |
All zydus pharmaceuticals (usa) recalls, newest first
95 totalAbout 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.