Rosuvastatin recalls

The FDA has published 8 recalls involving Rosuvastatin since 2023. The latest was reported on 14 Jan 2026. Most were for manufacturing (cgmp) deviations. Accord Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2023

Last 12 months1reported

Class I00% of total

Ongoing4latest 14 Jan 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 8 100%Class III 0 0%

Why rosuvastatin is recalled

Manufacturing (CGMP) Deviations788%
Potency & Assay113%

Companies

Brands

Rosuvastatin563%
Rosuvastatin Calcium113%

By year

2026113%
2025113%
2023675%

Ongoing rosuvastatin recalls

4 active

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin	AvKARE	Potency & Assay	Nationwide
16 Apr 2025Drug	CLASS II	Rosuvastatin Tablets 40mg recalled by Glenmark PharmaceuticalsRosuvastatin Calcium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin Tablets, USP, 5mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

All rosuvastatin recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin	AvKARE	Potency & Assay	Nationwide
16 Apr 2025Drug	CLASS II	Rosuvastatin Tablets 40mg recalled by Glenmark PharmaceuticalsRosuvastatin Calcium	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin Tablets, USP, 5mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
8 Mar 2023Drug	CLASS II	Rosuvastatin Tablets, USP, 5 mg* recalled by Accord HealthcareRosuvastatin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Rosuvastatin Tablets, USP, 10 mg* recalled by Accord HealthcareRosuvastatin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Rosuvastatin Tablets, USP 40 mg* recalled by Accord HealthcareRosuvastatin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Rosuvastatin Tablets, USP 20 mg* recalled by Accord HealthcareRosuvastatin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR

Should you stop taking Rosuvastatin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.