🔍 RecallPedia

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).

Class I - Dangerous
💊 Drugs Recalled: November 6, 2025 Fresenius Kabi USA Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Fresenius Kabi USA, LLC
Reason for Recall:
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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).

Product Codes/Lot Numbers:

Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0182-2026

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