Class II · Moderate risk
Famotidine Injection in Sodium Chloride Injection
CGMP Deviations
Famotidine Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
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).
Affected NDCs
63323-0739-11
63323-0739-12
Compare with the code on your package — it is the most precise check available.
Drug: Famotidine Category: Heartburn & Stomach Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Famotidine NDC 63323-0739 |
10 mg/mL | Injection, Solution Intravenous |
Fresenius Kabi USA, LLC | Rx |
- Recalling firm
- Fresenius Kabi USA, LLC
- NDC code
- 63323-739-11
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Nov 6, 2025 · FDA notice with lot numbers
- FDA recall number
- D-0182-2026 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Famotidine recalls
See all
Class II · Moderate risk
Ibuprofen and Famotidine Tablets 800mg/26.6mg
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II · Moderate risk
Famotidine Tablets
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class II · Moderate risk
Famotidine Tablets USP 40mg
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Class III · Low risk
Famotidine Injection
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Other recalls by Fresenius Kabi USA, LLC
All 2025 recalls
Class I · High risk
Tyenne (tocilizumab-aazg)
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Class I · High risk
Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
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