Rosuvastatin recalls
Rosuvastatin products have been recalled 5 times, most recently on 14 Jan 2026. The recalling company is usually Accord Healthcare. The most common reason is manufacturing (cgmp) deviations.
Total recalls5since 2023
Last 12 months1reported
Class I00% of total
Ongoing1latest 14 Jan 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 5 100%Class III 0 0%
Why rosuvastatin is recalled
Companies
Product types
By year
Ongoing rosuvastatin recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
All rosuvastatin recalls, newest first
5 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 5 mg* recalled by Accord HealthcareRosuvastatin | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg* recalled by Accord HealthcareRosuvastatin | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Rosuvastatin Tablets, USP 40 mg* recalled by Accord HealthcareRosuvastatin | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
| Drug | CLASS II | Rosuvastatin Tablets, USP 20 mg* recalled by Accord HealthcareRosuvastatin | Accord Healthcare | Manufacturing (CGMP) Deviations | PR |
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.