Quick Facts at a Glance
- Recall Date
- November 6, 2025
- Hazard Level
- HIGH
- Brands
- Famotidine, Fresenius Kabi USA, LLC
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Famotidine, Fresenius Kabi USA, LLC
- Product type
- Vialed injectable drug
- Model numbers
- Lot #: 6133156, 6133194, 6133388
- UPC codes
- 63323-739, 63323-739-11, 63323-739-12
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 6, 2025
Reported by FDA DRUG
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
Famotidine Injection is a hospital medication used to reduce stomach acid production. It is administered by healthcare professionals in clinical settings.
Why This Is Dangerous
Contaminated sterile injections pose risk of severe infection or endotoxin-related reactions if administered.
Industry Context
This recall is not part of a broader industry pattern, based on the current notice.
Real-World Impact
Hospitals and clinics must identify affected lots and replace or discard these vials. Consumers may face delays in treatment if alternatives are not readily available.
Practical Guidance
How to identify if yours is affected
- Check the lot numbers on the vial packaging: 6133156, 6133194, 6133388
- Verify expiry dates: 08/2026 and 10/2026
- Confirm NDC 63323-739-11 (unit of use) or 63323-739-12 (unit of sale)
Where to find product info
Identification is on the vial label and the accompanying packaging. FDA recall notices also list the lot numbers.
What timeline to expect
Refunds or replacements are coordinated through Fresenius Kabi and healthcare facilities; timelines vary by institution.
If the manufacturer is unresponsive
- Contact Fresenius Kabi customer service for escalation
- File a report with your hospital or supplier if replacements are delayed
How to prevent similar issues
- Implement lot-level inventory controls to segregate recalled vials
- Establish supplier notification processes for endotoxin-related issues
- Verify endotoxin testing results prior to patient administration when possible
Documentation advice
Keep recall letters, batch numbers, and any correspondence with suppliers or healthcare providers.
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Product Details
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials. NDC 63323-739-11 (unit of use) and 63323-739-12 (unit of sale). Quantity: 2,199,850 vials. Sold nationwide in the United States, including AK, HI, and PR. Lot numbers include 6133156, 6133194, 6133388. Expiry dates listed as 08/2026 and 10/2026.
Reported Incidents
No specific injuries or illnesses are described in the recall notice. The action is precautionary and based on quality testing results.
Key Facts
- Nationwide distribution including AK, HI, PR
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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