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Drug FDA Class I Ongoing Contamination / non-sterility

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

Fresenius Kabi USA, LLC Published Dec 3, 2025

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Fresenius Kabi USA, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Hazards

Endotoxin · primary

Affected products (1)

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

FAMOTIDINE · 2,199,850 vials

NDC: 63323-739, 63323-739-11, 63323-739-12
Code info: Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 6, 2025
  2. Published
    Dec 3, 2025
Recall number
D-0182-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.