Famotidine Injection, USP 20 mg per 2 mL

  • Out-of-specification endotoxin results
  • Company: Fresenius Kabi USA, LLC
  • Drugs
  • FDA
  • November 6, 2025

Product details

  • Famotidine Injection, USP 20 mg per 2 mL

Company announcement

Fresenius Kabi is voluntarily recalling three lots of Famotidine Injection due to out-of-specification endotoxin results.

The recall is nationwide, affecting users in the United States.

Non-serious adverse events including chills, fever, and altered mental status have been reported for one lot.

Risk:

Elevated endotoxin levels can precipitate severe systemic reactions such as sepsis and septic shock. Severe responses may include inflammatory and life-threatening immune responses and death.

Impacted states: Nationwide

Products:

- Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2mL fill in a 2 mL vial

- Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2mL fill in a 2 mL vial

- Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2mL fill in a 2 mL vial

Contact

For more information, call (866) 716-2459 or email productcomplaint.USA@fresenius-kabi.com.

View the original FDA notice

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