Class I U.S. Food and Drug Administration

Fresenius Kabi USA, LLC Famotidine Injection, USP, 20 mg per 2 mL , 2 mL vials recall: Microbial Contamination of Sterile Products

Recall published 11 months ago

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

The hazard: Microbial contamination

A micro-organism that should not be in this product was found in it, which is why the batch is being pulled rather than quietly reworked.

What the notice says: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0182-2026
Published
December 3, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Fresenius Kabi USA, LLC
Product type
Prescription & OTC drugs
Units affected
2,199,850 vials
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.

Products covered by this recall

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).

Check your product

The notice names 12 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 6133156
  • 6133194

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 08
  • 2026
  • 10
  • 2026. — 2
  • 199
  • 850 vials

NDC number

On the carton and again on the bottle or blister label.

  • 63323-739-11

Package size

Match the net weight or the piece count on the front of the pack.

  • 20 mg
  • 2 mL
  • 10 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

Fresenius Kabi USA, LLC — A micro-organism that should not be in this product was found in it, which is why the batch is being pulled rather than quietly reworked.

  1. Stop eating it and keep it separate from other food.
  2. Clean and sanitise the fridge shelf, container or surface it was stored on.
  3. Read the official notice for the organism named — the advice for Listeria, Salmonella and hepatitis A is not the same.
  4. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Company contact: Fresenius Kabi USA, LLC — 3 Corporate Dr, Lake Zurich, IL, 60047-8930

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Fresenius Kabi USA, LLC prescription & otc drugs recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 6133156, 6133194; best-by date 08 or 2026. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.

Where was the recalled product sold?

It was distributed nationwide.

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