Class III · Low risk
Ezetimibe and Simvastatin Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Is Simvastatin recalled?
Yes — there is an active recall. 5 ongoing FDA recalls mention Simvastatin (41 total). Check the affected lots below.
Most common reason: cGMP deviation (18 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Simvastatin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Simvastatin recalls on record
none so far in 2026; 41 on record, newest first
Class II · Moderate risk
Simvastatin USP 40 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP 20 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP
CGMP deviations.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin Tablets
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Class II · Moderate risk
Simvastatin 40 mg tablets
cGMP Deviations
Class II · Moderate risk
Simvastatin 10 mg tablets
cGMP Deviations
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Simvastatin
cGMP deviations
Class II · Moderate risk
Simvastatin Tablets USP 80 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 40 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 20 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Simvastatin Tablets USP 5 mg Rx Only
CGMP Deviations: recalling drug products following an FDA inspection.
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.