Cyclophosphamide recalls

The FDA has published 6 recalls involving Cyclophosphamide since 2019. The latest was reported on 12 Aug 2026. Most were for packaging defects. X-Gen Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2019

Last 12 months2reported

Class I233% of total

Ongoing3latest 12 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 1 0 0Nov 0 0 0Feb 0 0 0May 0 0 2Aug 0 0

Severity split

Class I 2 33%Class II 2 33%Class III 2 33%

Why cyclophosphamide is recalled

Companies

By year

2026233%
2025117%
2024233%
2019117%

Ongoing cyclophosphamide recalls

3 active

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS I	Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled	Sunny Pharmtech	Particulate Matter	Nationwide
12 Aug 2026Drug	CLASS I	Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled	Sunny Pharmtech	Particulate Matter	Nationwide
24 Sep 2025Drug	CLASS II	Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide	Sandoz	Manufacturing (CGMP) Deviations	Nationwide

All cyclophosphamide recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026Drug	CLASS I	Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled	Sunny Pharmtech	Particulate Matter	Nationwide
12 Aug 2026Drug	CLASS I	Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled	Sunny Pharmtech	Particulate Matter	Nationwide
24 Sep 2025Drug	CLASS II	Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide	Sandoz	Manufacturing (CGMP) Deviations	Nationwide
10 Apr 2024Drug	CLASS III	Cyclophosphamide for Injection, USP, 500mg/vial recalled	X-Gen Pharmaceuticals	Packaging Defects	Nationwide
10 Apr 2024Drug	CLASS III	Cyclophosphamide for Injection, USP, Lyophilized recalled	X-Gen Pharmaceuticals	Packaging Defects	Nationwide
21 Aug 2019Drug	CLASS II	Cyclophosphamide 840 MG / NS IVPB recalled by Infusion Options	Infusion Options	Sterility	NY

Should you stop taking Cyclophosphamide?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.