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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

Famotidine Injection Recalled for Microbial Contamination

Agency Publication Date: November 26, 2025
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Summary

Fresenius Kabi USA, LLC is recalling approximately 2,199,850 vials of Famotidine Injection, USP (20 mg per 2 mL), a sterile medication used to treat stomach ulcers and acid reflux. The recall was initiated because testing showed the products contained endotoxin levels that exceeded safe limits, which indicates potential microbial contamination. Consumers who have this medication should contact their healthcare provider or pharmacist for guidance.

Risk

The product may contain bacterial endotoxins which, when injected, can cause serious inflammatory responses, including fever, chills, and life-threatening septic shock.

What You Should Do

  1. Check your Famotidine Injection vials for lot numbers 6133156, 6133194 (Expiration 08/2026) or lot number 6133388 (Expiration 10/2026).
  2. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL)
Variants: 2 mL vials, Rx only
Lot Numbers:
6133156 (Exp Date: 08/2026)
6133194 (Exp Date: 08/2026)
6133388 (Exp Date: 10/2026)
NDC:
63323-739-11
63323-739-12

Quantity affected: 2,199,850 vials

Product Images

Vial label for Famotidine Injection, USP 20 mg per 2 mL Lot: 6133194, 2 mL

Vial label for Famotidine Injection, USP 20 mg per 2 mL Lot: 6133194, 2 mL

Vial label for Famotidine Injection, USP 20 mg per 2 mL Lot: 6133388, 2 mL

Vial label for Famotidine Injection, USP 20 mg per 2 mL Lot: 6133388, 2 mL

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97945
Status: Active
Manufacturer: Fresenius Kabi USA, LLC
Sold By: wholesalers; hospitals; clinics
Manufactured In: United States
Units Affected: 2,199,850 vials
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 FDA Press Release 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.