Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Rosuvastatin recalled?

Yes — there is an active recall. 4 ongoing FDA recalls mention Rosuvastatin (13 total). Check the affected lots below.

Most common reason: cGMP deviation (11 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Rosuvastatin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Rosuvastatin recalls on record

none so far in 2026; 13 on record, newest first
Class II · Moderate risk

Rosuvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7971-3 D-0520-2023
Class II · Moderate risk

Rosuvastatin Tablets

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-7086-3 D-0519-2023
Class II · Moderate risk

Rosuvastatin Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-287-10 D-0407-2023
Class II · Moderate risk

Rosuvastatin Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-286-15 D-0406-2023
Class II · Moderate risk

Rosuvastatin Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-285-15 D-0405-2023
Class II · Moderate risk

Rosuvastatin Tablets

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-284-15 D-0404-2023
Class II · Moderate risk

Rosuvastatin Calcium

Labeling: Label Mixup: ROSUVASTATIN CALCIUM, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: IBUPROFEN, Tablet, 400 mg, NDC 67877029401, Pedigree: W002577, EXP: 6/3/2014; ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD21846_49, EXP: 5/1/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-887-2014