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

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.

Pravastatin recalls on record

none so far in 2026; 17 on record, newest first
Class II · Moderate risk

Pravastatin Sodium Tablets

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

Ongoing cGMP deviation Preferred Pharmaceuticals, Inc. NDC 68788-8215-9 D-0521-2023
Class II · Moderate risk

Pravastatin Sodium Tablets

Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.

Terminated Particulate / foreign matter International Laboratories, Inc. NDC 54458-926-16 D-0234-2018
Class II · Moderate risk

Pravastatin Sodium Tablets

Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.

Terminated Particulate / foreign matter International Laboratories, Inc. NDC 54458-927-16 D-0233-2018
Class II · Moderate risk

Pravastatin Sodium USP

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.

Terminated Particulate / foreign matter Lupin Limited NDC 68180-487-09 D-0092-2018
Class I · High risk

Pravastatin Sodium Tablets

Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.

Terminated Labeling / mix-up International Laboratories, Inc. NDC 54458-925-16 D-0102-2018
Class III · Low risk

Pravastatin Sodium Tablets

Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

Terminated Impurity / degradation Dr. Reddy's Laboratories, Inc. NDC 55111-229-90 D-1038-2017
Class III · Low risk

Glenmark Pravastatin Sodium Tablets

Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.

Terminated Chemical / undeclared Glenmark Generics Inc., USA NDC 68462-197-90 D-330-2013