Simvastatin recalls

The FDA has published 29 recalls involving Simvastatin since 2014. The latest was reported on 10 May 2023. Most were for manufacturing (cgmp) deviations. Accord Healthcare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls29since 2014

Last 12 months0reported

Class I00% of total

Ongoing4latest 10 May 2023

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 22 76%Class III 7 24%

Why simvastatin is recalled

Companies

By year

20231862%
202013%
201913%
201813%
201613%
2015310%
2014414%

Ongoing simvastatin recalls

4 active

Reported	Class	Recall	Company	Reason	Where
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 40 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 20 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 10 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 80 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

All simvastatin recalls, newest first

29 total

Reported	Class	Recall	Company	Reason	Where
10 May 2023Drug	CLASS II	Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023Drug	CLASS II	Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
10 May 2023Drug	CLASS II	Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals	PD-Rx Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 40 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 20 mg, Packaged as: a) bottle recalled	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 10 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin 40 mg tablets, packaged in a) 30-count bottles recalled	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin Tablets, USP, 80 mg recalled by Preferred Pharmaceuticals	Preferred Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Simvastatin 10 mg tablets, packaged in a) 30-count bottles recalled	RemedyRepack	Manufacturing (CGMP) Deviations	Nationwide
5 Apr 2023Drug	CLASS II	Simvastatin recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
5 Apr 2023Drug	CLASS II	Simvastatin recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
5 Apr 2023Drug	CLASS II	Simvastatin, USP, 40 mg recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
5 Apr 2023Drug	CLASS II	Simvastatin recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
8 Mar 2023Drug	CLASS II	Simvastatin Tablets, USP, 10 mg recalled by Accord HealthcareSimvastatin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Simvastatin Tablets USP 80 mg recalled by Accord HealthcareSimvastatin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Simvastatin Tablets USP 5 mg recalled by Accord HealthcareSimvastatin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Simvastatin Tablets USP 20 mg recalled by Accord HealthcareSimvastatin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
8 Mar 2023Drug	CLASS II	Simvastatin Tablets USP 40 mg recalled by Accord HealthcareSimvastatin	Accord Healthcare	Manufacturing (CGMP) Deviations	PR
22 Apr 2020Drug	CLASS II	Simvastatin Tablets, USP 40mg recalled by Aurobindo Pharma USASimvastatin	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
4 Sep 2019Drug	CLASS III	Simvastatin Tablets, USP 40 mg recalled by Aurobindo Pharma USASimvastatin	Aurobindo Pharma USA	Other	Nationwide
24 Jan 2018Drug	CLASS III	Simvastatin Tablets, USP, 40 mg recalled by Hetero Labs, Ltd. - Unit IIISimvastatin	Hetero Labs Ltd. - Unit III	Other	Nationwide
20 Apr 2016Drug	CLASS III	Simvastatin Tablets, USP 5 mg recalled by Biocon	Biocon	Potency & Assay	CA, OH, PA
18 Mar 2015Drug	CLASS III	Simvastatin Tablets, USP, 80mg recalled by Micro Labs Usa, Inc S	Micro Labs Usa Inc S	Potency & Assay	Nationwide
18 Mar 2015Drug	CLASS III	Simvastatin Tablets, USP, 20mg a) bottle (42517-0020-10) recalled	Micro Labs Usa Inc S	Potency & Assay	Nationwide
18 Mar 2015Drug	CLASS III	Simvastatin Tablets, USP, 40mg recalled by Micro Labs Usa, Inc S	Micro Labs Usa Inc S	Potency & Assay	Nationwide
19 Nov 2014Drug	CLASS III	Simvastatin Tablets, USP, 10 mg recalled by Micro Labs Usa, Inc S	Micro Labs Usa Inc S	Potency & Assay	NY
29 Jan 2014Drug	CLASS II	Simvastatin, Tablet, 5 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
29 Jan 2014Drug	CLASS II	Simvastatin, Tablet, 40 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Simvastatin Tablet, 20 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

Should you stop taking Simvastatin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.