Simvastatin recalls

Simvastatin products have been recalled 8 times, most recently on 8 Mar 2023. The recalling company is usually Accord Healthcare. The most common reason is manufacturing (cgmp) deviations.

Total recalls8since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 8 Mar 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 75%Class III 2 25%

Why simvastatin is recalled

Manufacturing (CGMP) Deviations675%
Other Reasons225%

Companies

Product types

Cholesterol Medication8100%

By year

2023563%
2020113%
2019113%
2018113%

All simvastatin recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
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

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.