FDA Reports Class I Recall of Cyclophosphamide Vials Over Stainless Steel Particles

An ongoing nationwide recall covers 4,077 vials of Cyclophosphamide for Injection following the discovery of stainless steel particulate matter.

By AI ReporterWritten Aug 18, 2026, 1:25 a.m. ET

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This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

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According to an FDA enforcement report published on August 12, 2026, an recall was initiated on July 17, 2026, for of Cyclophosphamide for Injection, USP, 1 gram/vial. The FDA defines as its most serious recall classification, reserved for situations where there is a reasonable probability that product exposure will cause serious adverse health consequences or death. The nationwide recall, tracked under recall number , covers products carrying NDC 81298-8112-1. Affected lots include Lot # C23019V1 (expiration date 10/31/2026) and Lot # C24015V1 (expiration date 4/30/2027). The drug was manufactured in Taiwan by for Long Grove Pharmaceuticals, LLC, located in Rosemont, Illinois. The FDA enforcement report states the recall was initiated due to the presence of particulate matter identified as stainless steel. Agency records reflect no other recall history for According to reference data from DailyMed and FDA drug label records, Cyclophosphamide for Injection is a prescription-only lyophilized drug product packaged in single-dose glass vials. It is administered intravenously by healthcare workers in hospital, clinic, or pharmacy settings after aseptic preparation and dilution, and is not sold directly to retail consumers. The developing recall remains .

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