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Is Ezetimibe recalled?

18 FDA recalls mention Ezetimibe. The most recent are listed below.

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

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 III · Low risk Completed Mar 27, 2024

NEXLIZET (bempedoic acid and ezetimibe) tablets, 180 mg/10 mg, 30-count bottle, Rx only, Manufactured for: Esperion Therapeutics…

Reason Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.

Esperion NDC 72426-818-03 D-0441-2024

Class III · Low risk Completed Aug 16, 2023

Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann…

Reason Failed dissolution specifications: below specification results at stability 12-month

Esperion NDC 72426-818-03 D-1143-2023

Class II · Moderate risk Terminated Oct 14, 2021

Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC…

Reason Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity

Golden State Medical Supply Inc. NDC 51407-193-05 D-0228-2022

Class II · Moderate risk Terminated Oct 14, 2021

Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories…

Reason Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity…

Golden State Medical Supply Inc. D-0227-2022

Class II · Moderate risk Terminated Oct 5, 2021

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's…

Reason Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity…

Dr. Reddy's Laboratories, Inc. NDC 43598-743-05 D-0085-2022

Class II · Moderate risk Terminated Oct 5, 2021

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90)…

Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

Dr. Reddy's Laboratories, Inc. NDC 43598-743-30 D-0084-2022

Class II · Moderate risk Terminated Oct 5, 2021

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and…

Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

Dr. Reddy's Laboratories, Inc. NDC 43598-745-30 D-0083-2022

Class II · Moderate risk Terminated Oct 5, 2021

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90)…

Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

Dr. Reddy's Laboratories, Inc. NDC 43598-744-30 D-0082-2022

Class II · Moderate risk Terminated Oct 5, 2021

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10)…

Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

Dr. Reddy's Laboratories, Inc. NDC 43598-742-90 D-0081-2022

Class II · Moderate risk Terminated Mar 15, 2021

EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. D-0484-2021

Class II · Moderate risk Terminated Jan 15, 2019

Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd…

Reason Presence of Foreign Substance: Product complaint of black speckles observed on tablets.

Dr. Reddy's Laboratories, Inc. NDC 43598-586-10 D-0389-2019

Class II · Moderate risk Terminated Aug 14, 2015

Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contains 10 mg ezetimibe and 20 mg simvastatin, Rx Only…

Reason Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.

Merck Sharp & Dohme, Wilson Facility NDC 66582-0312-82 D-0007-2016

Class II · Moderate risk Terminated Nov 14, 2014

Ezetimibe active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…

Attix Pharmaceuticals D-670-2015

Class III · Low risk Terminated Jan 13, 2014

Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC…

Reason Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or…

Merck & Co Inc NDC 66582-323-30 D-1312-2014

Class III · Low risk Terminated Jan 13, 2014

Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC…

Reason This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which…

Merck & Co Inc NDC 66582-322-30 D-1311-2014

Class III · Low risk Terminated Jan 13, 2014

Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC…

Reason This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which…

Merck & Co Inc NDC 66582-321-30 D-1310-2014

Class III · Low risk Terminated Jan 13, 2014

Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC…

Reason This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which…

Merck & Co Inc NDC 66582-320-30 D-1309-2014