Rosuvastatin Tablets
Out of specification for dissolution.
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.
Out of specification for dissolution.
CGMP Deviations
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
cGMP Deviations
cGMP Deviations
cGMP Deviations
cGMP Deviations
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
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.
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