Famotidine Injection Recalled Due to CGMP Deviations

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for famotidine injection, 20 mg, 50 mL. The affected batches have been identified as Lots NC188586 (expires February 2027) and NC188913 (expires March 2027).
• The recall was initiated by Baxter Healthcare Corporation due to Current Good Manufacturing Practice (CGMP) deviations, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Famotidine is used to treat stomach ulcers, erosive esophagitis, and gastroesophageal reflux disease (GERD).

The FDA has issued a Class II recall for famotidine injection, 20 mg, 50 mL. This product is being recalled by Baxter Healthcare Corporation based in Deerfield, Illinois. The recall was initiated on August 6, 2026, and received a Class II classification on August 28, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the CGMP deviations. This deficiency affects Lots NC188586 and NC188913, which will expire in February and March 2027, respectively. Baxter Healthcare Corporation sent out a public notice via letter; no press release has been issued for this recall.

Famotidine is used to treat stomach ulcers, erosive esophagitis, and GERD. The injection is a short-term alternative for hospitalized patients or for people who cannot take oral medication. Pharmacists should identify and quarantine Lots NC188586 and NC188913, remove them from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. September 9, 2026. Accessed September 9, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221821