Famotidine Injection, Solution
FDA Recall NDC 0338-5197
Latest: Class II · Status: Ongoing · Initiated Aug 06, 2026 · 2 enforcement reports
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Famotidine (NDC 0338-5197). A significant event, classified as Class II, was initiated on Aug 06, 2026 by Baxter Healthcare Corporation. The reported reason for this action was: "CGMP Deviations"
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
Class II Ongoing
CGMP Deviations
Aug 06, 2026
Sep 09, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99500
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide; Puerto Rico; and Chile.
Product Description
Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-5197-41.
Batch or Lot Expiration Information
Lot# NC188586, Exp Date: 02/28/2027
Lot# NC188913, Exp Date: 3/9/2027.
Affected Packages Involved in this Recall
0338-5197-41Famotidine
Class II Terminated
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Apr 24, 2014
Dec 17, 2014
19,152 Containers
Recall Profile & Regulatory Data
Event ID
68171
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 16, 2015
Product Description
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.
Batch or Lot Expiration Information
Lot# : NC082768, Exp 12/23/2014
Affected Packages Involved in this Recall
0338-5197-41Famotidine
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.
