Pravastatin Sodium Tablets
CGMP Deviations
Yes — there is an active recall. 6 ongoing FDA recalls mention Pravastatin (17 total). Check the affected lots below.
Most common reason: cGMP deviation (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pravastatin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Failed Dissolution Specifications: results below specifications
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their 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.
CGMP Deviations: recalling drug products following an FDA inspection.
Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.
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