Medications & Supplements/Prescription Drugs

Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Potential Impurities

Agency Publication Date: October 29, 2021

Summary

Dr. Reddy's Laboratories is recalling approximately 47,345 bottles of Ezetimibe and Simvastatin (generic Vytorin) tablets across multiple dosage strengths. The medication was manufactured using an ingredient that failed conductivity quality tests, and some bottles labeled as 10 mg/40 mg tablets were found to contain 10 mg/10 mg tablets instead. No injuries or illnesses have been reported in connection with this recall.

Risk

The use of medication manufactured with out-of-specification ingredients may lead to potential impurities that could affect the quality or stability of the drug. Additionally, the presence of lower-strength tablets (10 mg/10 mg) in a higher-strength bottle (10 mg/40 mg) can lead to patients receiving an inadequate dose of their cholesterol-lowering medication, potentially making their treatment less effective.

What You Should Do

This recall affects Dr. Reddy's Ezetimibe and Simvastatin Tablets in strengths of 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, sold in bottles containing 30, 90, 500, or 1000 tablets.
Check the bottle label for NDC codes such as 43598-742-90, 43598-744-30, 43598-745-30, or 43598-743-30 and lot numbers such as L100256, L100298, L100160, or L100158. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/10 mg, 90 count)

Variants: 10 mg/10 mg, 90 count bottle

Lot Numbers:

L100256 (Exp 01/2023)

NDC:

43598-742-90

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/10 mg, 1000 count)

Variants: 10 mg/10 mg, 1000 count bottle

Lot Numbers:

L100257 (Exp 01/2023)

NDC:

43598-742-10

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/20 mg, 30 count)

Variants: 10 mg/20 mg, 30 count bottle

Lot Numbers:

L100298 (Exp 01/2023)

L100304 (Exp 01/2023)

NDC:

43598-744-30

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/20 mg, 90 count)

Variants: 10 mg/20 mg, 90 count bottle

Lot Numbers:

L100235 (Exp 01/2023)

NDC:

43598-744-90

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/80 mg, 30 count)

Variants: 10 mg/80 mg, 30 count bottle

Lot Numbers:

L100160 (Exp 01/2023)

NDC:

43598-745-30

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/80 mg, 90 count)

Variants: 10 mg/80 mg, 90 count bottle

Lot Numbers:

L100249 (Exp 01/2023)

NDC:

43598-745-90

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/80 mg, 500 count)

Variants: 10 mg/80 mg, 500 count bottle

Lot Numbers:

L100250 (Exp 01/2023)

NDC:

43598-745-05

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/40 mg, 30 count)

Variants: 10 mg/40 mg, 30 count bottle

Lot Numbers:

L100158 (Exp 12/2022)

NDC:

43598-743-30

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/40 mg, 90 count)

Variants: 10 mg/40 mg, 90 count bottle

Lot Numbers:

L100159 (Exp 12/2022)

NDC:

43598-743-90

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/40 mg, 500 count)

Variants: 10 mg/40 mg, 500 count bottle

Lot Numbers:

L100208 (Exp 01/2023)

NDC:

43598-743-05

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88798

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 5 products (a) 776 bottles, b) 84 bottles; a) 30,839 bottles, b) 3,830 bottles; a) 3,444 bottles b) 469 bottles c) 142 bottles; a) 11,590 bottles b) 3,585 bottles; 696 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects Dr. Reddy's Ezetimibe and Simvastatin Tablets in strengths of 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, sold in bottles containing 30, 90, 500, or 1000 tablets.

Check the bottle label for NDC codes such as 43598-742-90, 43598-744-30, 43598-745-30, or 43598-743-30 and lot numbers such as L100256, L100298, L100160, or L100158. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/10 mg, 90 count)

Variants: 10 mg/10 mg, 90 count bottle

Lot Numbers:

L100256 (Exp 01/2023)

NDC:

43598-742-90

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/10 mg, 1000 count)

Variants: 10 mg/10 mg, 1000 count bottle

Lot Numbers:

L100257 (Exp 01/2023)

NDC:

43598-742-10

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/20 mg, 30 count)

Variants: 10 mg/20 mg, 30 count bottle

Lot Numbers:

L100298 (Exp 01/2023)

L100304 (Exp 01/2023)

NDC:

43598-744-30

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/20 mg, 90 count)

Variants: 10 mg/20 mg, 90 count bottle

Lot Numbers:

L100235 (Exp 01/2023)

NDC:

43598-744-90

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/80 mg, 30 count)

Variants: 10 mg/80 mg, 30 count bottle

Lot Numbers:

L100160 (Exp 01/2023)

NDC:

43598-745-30

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/80 mg, 90 count)

Variants: 10 mg/80 mg, 90 count bottle

Lot Numbers:

L100249 (Exp 01/2023)

NDC:

43598-745-90

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/80 mg, 500 count)

Variants: 10 mg/80 mg, 500 count bottle

Lot Numbers:

L100250 (Exp 01/2023)

NDC:

43598-745-05

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/40 mg, 30 count)

Variants: 10 mg/40 mg, 30 count bottle

Lot Numbers:

L100158 (Exp 12/2022)

NDC:

43598-743-30

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/40 mg, 90 count)

Variants: 10 mg/40 mg, 90 count bottle

Lot Numbers:

L100159 (Exp 12/2022)

NDC:

43598-743-90

Product: Dr. Reddy's Ezetimibe and Simvastatin Tablets (10 mg/40 mg, 500 count)

Variants: 10 mg/40 mg, 500 count bottle

Lot Numbers:

L100208 (Exp 01/2023)

NDC:

43598-743-05

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88798

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 5 products (a) 776 bottles, b) 84 bottles; a) 30,839 bottles, b) 3,830 bottles; a) 3,444 bottles b) 469 bottles c) 142 bottles; a) 11,590 bottles b) 3,585 bottles; 696 bottles)

Distributed To: Nationwide