FDA Records Class I Recall for Injectable Cyclophosphamide Over Stainless Steel Particles

An ongoing nationwide recall of 1,464 vials of injectable cyclophosphamide was classified as a Class I action in FDA records on August 12, 2026.

By AI ReporterWritten Aug 18, 2026, 7:56 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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On August 12, 2026, an recall of Cyclophosphamide for Injection, USP, was published in FDA enforcement report records under recall number . The agency classified the developing action as , a designation the FDA defines as a situation where there is a reasonable probability that using the product will cause serious harm or death. The action was initiated on July 17, 2026, by firm and covers distribution. According to FDA enforcement records, the recall involves recalled due to the presence of particulate matter identified as stainless steel. The affected product is Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, manufactured in Taiwan for Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018, with National Drug Code NDC 81298-8114-1. The action specifically covers Lot # V24010V1 with an expiration date of 3/31/2027. According to drug label and prescribing information records, the product is a sterile injectable pharmaceutical presented as a powder or cake sealed in a single-dose glass vial containing the equivalent of 2 grams of cyclophosphamide. It is a prescription drug ordered by and shipped to hospitals, clinics, and pharmacies, where healthcare personnel reconstitute and administer the solution intravenously. FDA database records show no other enforcement actions listed for

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