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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.: Clopidogrel Tablets Recalled Due to Failed Dissolution Testing

Agency Publication Date: December 11, 2018
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Summary

Dr. Reddy's Laboratories is recalling 4,404 blister packs of Clopidogrel Tablets (300 mg), a medication typically used to prevent blood clots. The recall was initiated because certain lots failed dissolution testing during routine stability checks, meaning the medication may not break down or release properly in the body. This issue could result in the drug being less effective than intended for patients. Consumers who have these tablets should consult their healthcare provider or pharmacist immediately.

Risk

If the tablets do not dissolve correctly, the medication may not be fully absorbed into the bloodstream, potentially failing to prevent blood clots or other cardiovascular events as intended.

What You Should Do

  1. Check your medication packaging for Clopidogrel Tablets, USP, 300 mg in 30-count (5 x 6 unit-dose) blister packs with NDC 55111-671-31.
  2. Identify if your product is from the affected lots by looking for Lot Number T700423 (Expiration 08/2019) or Lot Number T800310 (Expiration 03/2020).
  3. Contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and to discuss any concerns regarding the effectiveness of your medication.
  4. Return any unused tablets from these specific lots to the pharmacy where you purchased them for a refund.
  5. Contact Dr. Reddy's Laboratories, Inc. at their Princeton, New Jersey office or through your distributor for further instructions 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

💰Full Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack
Model:
NDC 55111-671-31
Recall #: D-0294-2019
Lot Numbers:
T700423 (Exp 08/2019)
T800310 (Exp 03/2020)
Date Ranges: Expiration 08/2019, Expiration 03/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81748
Status: Resolved
Manufacturer: Dr. Reddy's Laboratories, Inc.
Sold By: Major distributors
Manufactured In: India, United States
Units Affected: 4,404 (30 count blister packs)
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.