Famotidine Injection, Solution
FDA Recall NDC 63323-739
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Famotidine (NDC 63323-739). A significant event, classified as Class I, was initiated on Nov 06, 2025 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
November 2025 Class I Recall: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recall Number
Class I Ongoing
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Nov 06, 2025
Dec 03, 2025
2,199,850 vials
Recall Profile & Regulatory Data
Event ID
97945
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States as well as AK, HI, and PR.
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).
Batch or Lot Expiration Information
Lot# : 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Affected Packages Involved in this Recall
63323-739-11Product
63323-739-12Product
Class III Terminated
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Jun 17, 2020
Jul 29, 2020
N/A
Recall Profile & Regulatory Data
Event ID
85916
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
HF Acquisition Co. LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
The vials were distributed to one consignee located in CT.
Termination Date
Apr 13, 2021
Product Description
Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12
Batch or Lot Expiration Information
Lot# : 6122639, Exp. Date 08/2021
Affected Packages Involved in this Recall
63323-739-11Product
63323-739-12Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
