Ezetimibe And Simvastatin

Ezetimibe And Simvastatin recalls: 9 FDA reports

Recalls involving Ezetimibe And Simvastatin. What was wrong with each batch, and how the FDA graded the risk.

9Reports
0Class I
1Ongoing
2025-06-18Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II8
Class III1

By year reported

YearReports
20218
20251
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceutic

D-0462-2025  ·  Class III  ·  reported 2025-06-18  ·  Ongoing

Why it was recalled
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.
Product
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
Where it went
Nationwide USA and PR
How much
6,759 Con - 90 bottle pack

Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Red

D-0227-2022  ·  Class II  ·  reported 2021-11-17  ·  Terminated

Why it was recalled
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
Product
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05
Where it went
Distributed to two distributors located in AZ and MO
How much
a) 101 b) 145 bottles

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

D-0228-2022  ·  Class II  ·  reported 2021-11-17  ·  Terminated

Why it was recalled
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Product
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05
Where it went
Distributed to two distributors located in AZ and MO
How much
49

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 4

D-0084-2022  ·  Class II  ·  reported 2021-11-10  ·  Terminated

Why it was recalled
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Product
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) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Where it went
Nationwide in the US
How much
a) 11,590 bottles b) 3,585 bottles

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 4

D-0082-2022  ·  Class II  ·  reported 2021-11-10  ·  Terminated

Why it was recalled
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Product
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) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Where it went
Nationwide in the US
How much
a) 30,839 bottles, b) 3,830 bottles

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 4

D-0083-2022  ·  Class II  ·  reported 2021-11-10  ·  Terminated

Why it was recalled
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Product
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 c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA
Where it went
Nationwide in the US
How much
a) 3,444 bottles b) 469 bottles c) 142 bottles

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

D-0085-2022  ·  Class II  ·  reported 2021-11-10  ·  Terminated

Why it was recalled
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
Product
Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05
Where it went
Nationwide in the US
How much
696 bottles

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

D-0081-2022  ·  Class II  ·  reported 2021-11-10  ·  Terminated

Why it was recalled
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Product
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) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA, , packaged in bottles.
Where it went
Nationwide in the US
How much
a) 776 bottles, b) 84 bottles

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

D-0484-2021  ·  Class II  ·  reported 2021-06-02  ·  Terminated

Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product
EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS
Where it went
FL, GA, SC
How much
7 CARTON
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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