FDA-Drug2026-09-09Class IIPROCESSING DEFECT
Baxter famotidine injection recalled for manufacturing quality deviations
What this means
Baxter Healthcare is recalling two lots of famotidine injection (20 mg in 50 mL sodium chloride) due to deviations from manufacturing standards. The affected lots may not meet quality and sterility requirements.
- If you are a healthcare provider or facility, check your inventory for lots NC188586 (expires 02/28/2027) or NC188913 (expires 3/9/2027).
- Do not use affected lots. Return or destroy them according to your facility's procedure.
- Contact Baxter or the FDA if you have questions about your specific lot number.
The agency's original wording
Hazard
CGMP Deviations
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide; Puerto Rico; and Chile.
Affected count
N/A
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0809-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
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