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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Ezetimibe and Simvastatin Tablets Recalled for Foreign Black Speckles

Agency Publication Date: January 22, 2019
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Summary

Dr. Reddy's Laboratories, Inc. is recalling 118 bottles of Ezetimibe and Simvastatin (10mg/80 mg), a prescription medication used to treat high cholesterol. This recall was issued after a consumer complained about seeing black speckles, an unidentified foreign substance, on the tablets. The recall affects 1000-count bottles of the medication that were distributed nationwide.

Risk

The presence of an unknown foreign substance in a prescription drug poses a health risk because the material has not been identified and could cause irritation, allergic reactions, or other adverse health effects if swallowed. No specific injuries have been reported, but the safety and purity of the medication cannot be guaranteed.

What You Should Do

  1. Check your prescription bottle to see if you have Ezetimibe and Simvastatin Tablets (10mg/80 mg) in 1000-count bottles.
  2. Look for the National Drug Code (NDC) 43598-586-10 and check for lot numbers 43E021 or 43E023, both with an expiration date of 01/2020.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you should continue taking the medication or obtain a new supply.
  4. Return any unused tablets from the affected lots to your pharmacy to receive a refund and to ensure the product is properly handled.
  5. Contact Dr. Reddy's Laboratories at their Princeton, NJ headquarters if you have further questions regarding the return process.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Return affected medication to the place of purchase for a refund and consult a doctor.

Affected Products

Product: Ezetimibe and Simvastatin Tablets 10mg/80 mg (1000-count bottle)
Model:
NDC 43598-586-10
Recall #: D-0389-2019
Lot Numbers:
43E021 (Exp. 01/2020)
43E023 (Exp. 01/2020)
Date Ranges: Expiration 01/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81936
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Pharmacies
Manufactured In: Israel, United States
Units Affected: 118 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 ยท 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.