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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

Pfizer Manufacturing Deutschland GmbH: Atorvastatin Calcium Tablets Recalled for Microbial Contamination

Agency Publication Date: January 9, 2018
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Summary

Pfizer Manufacturing Deutschland GmbH has recalled several lots of Atorvastatin calcium Film-Coated Tablets, the generic version of the cholesterol medication Lipitor, due to microbial contamination. Approximately 31 million tablets in various strengths (20 mg, 40 mg, and 80 mg) are affected by this recall. While these specific products were manufactured for export and were not distributed within the United States or its territories, consumers who may have obtained these medications abroad should be aware of the potential health risks. If you are using this medication, contact your healthcare provider or pharmacist for guidance and to obtain a safe replacement.

Risk

The tablets are contaminated with microorganisms, which can lead to infections or other adverse health effects, particularly in individuals with weakened immune systems or underlying health conditions.

What You Should Do

  1. Identify your medication by checking the packaging for 'Atorvastatin calcium Film-Coated Tablets' in 20 mg, 40 mg, or 80 mg strengths.
  2. Check the bulk product batch or packaged lot numbers and expiration dates on your medication container to see if they match the following: for 80 mg tablets, look for batches S55350 (Exp. 20 APR 2018), S55378 (Exp. 07 MAR 2018), S55386 (Exp. 14 MAR 2018), S53284 (Exp. 14 FEB 2018), or S53283 (Exp. 10 FEB 2018).
  3. For 40 mg tablets, check for batches S53287 (Exp. 16 FEB 2018) or S33417 (Exp. 03 FEB 2018).
  4. For 20 mg tablets, check for batches S33445 (Exp. 17 FEB 2018), S33452 (Exp. 24 FEB 2018), or S33397 (Exp. 07 FEB 2018).
  5. If your medication is part of this recall, contact your healthcare provider or pharmacist immediately for guidance on continuing your treatment. Do not stop taking your medication without consulting a professional.
  6. Return any unused product to the pharmacy or place of purchase for a refund and contact Pfizer Manufacturing Deutschland GmbH for further instructions.
  7. 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

Contact healthcare provider and return product to pharmacy.

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 Film-Coated Tablets (80 mg SMT Tabs Bulk)
Model:
D-0212-2018
Lot Numbers:
S55350 (Exp. 20 APR 2018)
S55378 (Exp. 07 MAR 2018)
S55386 (Exp. 14 MAR 2018)
S53284 (Exp. 14 FEB 2018)
S53283 (Exp. 10 FEB 2018)
Date Ranges: Exp. 20 APR 2018, Exp. 07 MAR 2018, Exp. 14 MAR 2018, Exp. 14 FEB 2018, Exp. 10 FEB 2018
Product: Atorvastatin calcium Film-Coated Tablets (40 mg SMT G EP PR KR)
Model:
D-0212-2018
Lot Numbers:
S53287 (Exp. 16 FEB 2018)
S33417 (Exp. 03 FEB 2018)
Date Ranges: Exp. 16 FEB 2018, Exp. 03 FEB 2018
Product: Atorvastatin calcium Film-Coated Tablets (20 mg SMT G EP PR)
Model:
D-0212-2018
Lot Numbers:
S33445 (Exp. 17 FEB 2018)
S33452 (Exp. 24 FEB 2018)
Date Ranges: Exp. 17 FEB 2018, Exp. 24 FEB 2018
Product: Atorvastatin calcium Film-Coated Tablets (20 mg SMT G EP PR KR)
Model:
D-0212-2018
Lot Numbers:
S33397 (Exp. 07 FEB 2018)
Date Ranges: Exp. 07 FEB 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78682
Status: Resolved
Manufacturer: Pfizer Manufacturing Deutschland GmbH
Sold By: International distributors; German pharmacies
Manufactured In: Germany
Units Affected: a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets

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.