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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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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

International Laboratories, LLC: Clopidogrel Tablets Recalled Due to Label Mix-Up with Simvastatin Tablets

Agency Publication Date: February 1, 2018
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Summary

International Laboratories, LLC is recalling approximately 218,772 bottles of Clopidogrel tablets (75 mg), a medication used to prevent blood clots. The recall was issued because some bottles labeled as Clopidogrel actually contain Simvastatin (10 mg), which is a cholesterol-lowering medication. Consumers who unknowingly take Simvastatin instead of their prescribed Clopidogrel will not receive the blood-thinning benefits they require and may experience unintended side effects. You should contact your healthcare provider or pharmacist immediately to obtain the correct medication and return any unused bottles to the place of purchase for a refund.

Risk

Patients taking the wrong medication will miss their prescribed blood-thinning treatment, which increases the risk of serious cardiovascular events. Additionally, taking Simvastatin unintentionally may cause drug interactions or adverse side effects associated with cholesterol medication.

What You Should Do

  1. Check your prescription bottles to see if you have Clopidogrel Tablets, USP 75 mg (30-count bottles) with NDC number 54458-888-16.
  2. Check the bottle label for Lot # 117099A and an expiration date of 08/19 to determine if your specific bottle is affected.
  3. If your bottle matches these details, do not take the medication and contact your doctor, healthcare provider, or pharmacist immediately to ensure your treatment plan is not interrupted.
  4. Return any unused or affected bottles to the pharmacy or location where you purchased them to receive a full refund.
  5. Contact International Laboratories, LLC for further instructions or questions regarding this labeling error.
  6. For more information or to report concerns, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare guidance and product 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 75 mg (30-count bottles)
Model:
NDC 54458-888-16
Recall #: D-0472-2018
Lot Numbers:
117099A (Exp. 08/19)
Date Ranges: August 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78913
Status: Resolved
Manufacturer: International Laboratories, LLC
Sold By: pharmacies
Manufactured In: United States
Units Affected: 218772 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.