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
Summary
The FDA issued a Class I for Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, F by Fresenius Kabi USA, LLC. Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing..
Details
Source
Drug Recall
External ID
D-0182-2026
Action Date
2025-12-03
Status
Ongoing
Category
drug
Product 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).
Lot/Code Info: Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Quantity Affected: 2,199,850 vials
Reason for Recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Distribution
Nationwide within the United States as well as AK, HI, and PR.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-06
Company
Lake Zurich, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA, LLC have FDA actions?
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0182-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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