Fosfomycin Tromethamine Recalled Due to Failed Impurities Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for fosfomycin tromethamine granules for oral solution. The affected batch has been identified as Lot 5KA0405 (expires December 2026).
• The recall was initiated by Cipla USA, Inc due to failed impurities specifications, 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.
• Fosfomycin tromethamine is used to treat urinary tract infection and cystitis.

The FDA has issued a Class II recall for fosfomycin tromethamine granules for oral solution. This product is being recalled by Cipla USA, Inc based in Warren, New Jersey. The recall was initiated on September 18, 2026, and received a Class II classification on October 6, 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 after the product failed to meet impurities specifications. This issue affects Lot 5KA0405, which will expire in December 2026. Cipla USA sent out public notices via email, letter, fax, telephone, and personal visit; no press release has been issued for this recall.

Fosfomycin tromethamine is an antibiotic used to treat urinary tract infection as well as cystitis in women. Pharmacists should identify and quarantine Lot 5KA0405, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 14, 2026. Accessed October 14, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222882