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 Ezetimibe recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Ezetimibe (18 total). Check the affected lots below.
Most common reason: Failed specification (9 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ezetimibe. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Ezetimibe recalls on record
none so far in 2026; 18 on record, newest first
Class III · Low risk
NEXLIZET (bempedoic acid and ezetimibe)
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Class III · Low risk
Nexlizet (bempedoic acid and ezetimibe)
Failed dissolution specifications: below specification results at stability 12-month
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
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
Ezetimibe and Simvastatin Tablets 10-10mg 30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets 10mg/80 mg
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Class II · Moderate risk
Vytorin (ezetimibe and simvastatin)
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Class II · Moderate risk
Ezetimibe active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Class III · Low risk
Liptruzet (ezetimibe and atorvastin)
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
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