Class I · High risk
Cyclophosphamide for Injection
Presence of Particulate Matter; identified as stainless steel
Is Cyclophosphamide recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Cyclophosphamide (8 total). Check the affected lots below.
Most common reason: Labeling / mix-up (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cyclophosphamide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Cyclophosphamide recalls in 2026
2 initiated in 2026, 8 in total — newest first
Class I · High risk
Cyclophosphamide for Injection
Presence of Particulate Matter; identified as stainless steel
Class II · Moderate risk
Cyclophosphamide Injection 500 mg/5 mL
cGMP deviations: Temperature excursion during transportation.
Class III · Low risk
Cyclophosphamide for Injection
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk
Cyclophosphamide for Injection
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class II · Moderate risk
Cyclophosphamide 840 MG / 250 ML NS IVPB
Lack of Assurance of Sterility
Class II · Moderate risk
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Cyclophosphamide Monohydrate active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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