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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Apotex Inc.: Atorvastatin Calcium Tablets Recalled for Potential Foreign Tablet Contamination

Agency Publication Date: October 28, 2019
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Summary

Apotex Inc. is recalling 1,968 bottles of Atorvastatin Calcium (the generic version of Lipitor) 40 mg tablets because a single tablet of a different medication, Pravastatin 40 mg (the generic version of Pravachol), was found inside a bottle. While only one instance has been reported, this recall affects a specific lot distributed to several states. If you are taking this medication, you should contact your doctor or pharmacist immediately for guidance and a replacement.

Risk

Taking the wrong medication can lead to unexpected side effects or leave your underlying condition untreated. In this case, a patient might accidentally ingest Pravastatin instead of their prescribed Atorvastatin, though no injuries or adverse reactions have been reported to date.

What You Should Do

  1. Check your medication bottle for Atorvastatin Calcium Tablets, USP 40 mg in 1,000-count bottles with NDC 60505-2580-8.
  2. Verify if your bottle belongs to Lot RC5439 with an expiration date of 03/2022.
  3. If your bottle matches these details, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement.
  4. Return any unused portions of the affected lot to the pharmacy where you purchased it for a refund.
  5. Contact Apotex Inc. directly for further instructions regarding this recall.
  6. For additional questions, contact 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

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Atorvastatin Calcium Tablets, USP 40 mg (1,000 count bottle)
Model:
NDC 60505-2580-8
Recall #: D-0153-2020
Lot Numbers:
RC5439 (Exp. 03/2022)
Date Ranges: Exp. 03/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84107
Status: Resolved
Manufacturer: Apotex Inc.
Sold By: pharmacies
Manufactured In: Canada
Units Affected: 1968 bottles
Distributed To: Illinois, Mississippi, New Jersey, Ohio, Texas

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.