Is Simvastatin recalled?

41 FDA recalls mention Simvastatin. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Simvastatin.

Class III · Low risk Ongoing May 19, 2025

Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No…

Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time…

Glenmark Pharmaceuticals Inc., USA NDC 68462-323-90 D-0462-2025

Class II · Moderate risk Terminated Apr 6, 2023

Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0726-30 D-0561-2023

Class II · Moderate risk Terminated Apr 6, 2023

Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-008-30 D-0560-2023

Class II · Moderate risk Terminated Apr 6, 2023

Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma…

Reason CGMP deviations.

PD-Rx Pharmaceuticals, Inc. NDC 43063-0727-30 D-0558-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c)…

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

Preferred Pharmaceuticals, Inc. NDC 68788-9868-9 D-0525-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c)…

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

Preferred Pharmaceuticals, Inc. NDC 68788-9869-9 D-0524-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC…

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

Preferred Pharmaceuticals, Inc. NDC 68788-9429-9 D-0523-2023

Class II · Moderate risk Ongoing Mar 23, 2023

Simvastatin Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC…

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

Preferred Pharmaceuticals, Inc. NDC 68788-9747-9 D-0522-2023

Class II · Moderate risk Terminated Mar 20, 2023

Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-00), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-0060-01 D-0503-2023

Class II · Moderate risk Terminated Mar 20, 2023

Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-00), Rx…

Reason cGMP Deviations

RemedyRepack Inc. NDC 70518-0064-01 D-0496-2023

Class II · Moderate risk Terminated Mar 13, 2023

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx…

Reason cGMP deviations

Direct Rx NDC 61919-0431-90 D-0486-2023

Class II · Moderate risk Terminated Mar 13, 2023

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC…

Reason cGMP deviations

Direct Rx NDC 61919-0446-30 D-0485-2023

Class II · Moderate risk Terminated Mar 13, 2023

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle…

Reason cGMP deviations

Direct Rx NDC 61919-0688-30 D-0484-2023

Class II · Moderate risk Terminated Mar 13, 2023

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx…

Reason cGMP deviations

Direct Rx NDC 61919-0710-90 D-0483-2023

Class II · Moderate risk Terminated Feb 7, 2023