Rosuvastatin recalls

The FDA has published 13 recalls involving Rosuvastatin since 2014. 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 recalls13since 2014

Last 12 months1reported

Class I00% of total

Ongoing4latest 14 Jan 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 0 0Aug 0 0 0Nov 0 1 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 13 100%Class III 0 0%

Why rosuvastatin is recalled

Companies

Brands

Rosuvastatin538%
Rosuvastatin Calcium18%

By year

202618%
202518%
20231077%
201418%

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., USA	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

13 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., USA	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin 10mg tablets recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin 5mg tablets recalled by RemedyRepack	RemedyRepack	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 5mg tablets recalled by RemedyRepack	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Rosuvastatin 40mg tablets recalled by RemedyRepack	RemedyRepack	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
29 Jan 2014Drug	CLASS II	Rosuvastatin Calcium, Tablet, 5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

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.