Quality & complianceOfficial

FDA lists Class II recall of Cipla fosfomycin granules over impurity and degradation failure

🇺🇸 FDA enforcement report · Wed 14 Oct 2026

Cipla USA's Fosfomycin Tromethamine Granules for Oral Solution are subject to a nationwide Class II recall after failing impurities/degradation specifications, according to FDA's enforcement report.

The US Food and Drug Administration has published a Class II recall of Fosfomycin Tromethamine Granules for Oral Solution, marketed by Cipla USA, Inc. The entry appears in the agency's enforcement report dated 14 October 2026 under recall number D-0014-2027.

The stated reason for the recall is a failure to meet impurities/degradation specifications. The record on file does not say which impurity or degradation product was involved, what levels were found, or at which stage of testing the failure was identified.

FDA lists the recall as ongoing, with distribution across the United States nationwide. The material available does not include lot numbers, quantities, strengths, or expiry dates, and it does not say whether any adverse events have been reported.

For context, FDA defines a Class II recall as one involving a product that may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams should check whether any fosfomycin tromethamine supply in their chain comes from Cipla USA, and consult the full FDA record for batch details, which were not in the information reviewed.
  • Impurity and degradation failures are stability and specification issues, so manufacturers of similar products may want to review their own related-substances testing trends.
  • Pharmacovigilance and supply teams should monitor for further updates, as the recall status is ongoing and no health-hazard details were provided.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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