Reported Nov 7, 2025 · Announced · Updated Aug 26, 2026

Fresenius Kabi USA, LLC recalls Fresenius Kabi Famotidine Injection, USP 20 mg per 2 mL due to Out-of-specification endotoxin results

Fresenius Kabi USA, LLC

Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.

What you should do

Stop using the product and follow the return or refund instructions in the firm's announcement.

Is this the product you have?

  • Famotidine Injection
  • USP 20 mg per 2 mL BrandFresenius Kabi. Drugs

Why it was recalled

Out-of-specification endotoxin results

The agency has not ranked the risk yet — treat the notice as a caution.

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Where this came from

Source: U.S. Food & Drug Administration

Read the FDA (recalls & safety alerts) notice

Data as of Sep 19, 5:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.