Class I · High risk Ongoing
Cyclophosphamide for Injection
Reason 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.
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.
Class I · High risk Ongoing
Cyclophosphamide for Injection
Reason Presence of Particulate Matter; identified as stainless steel
Class II · Moderate risk Ongoing
Cyclophosphamide Injection 500 mg/5 mL
Reason cGMP deviations: Temperature excursion during transportation.
Class III · Low risk Terminated
Cyclophosphamide for Injection
Reason 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 Terminated
Cyclophosphamide for Injection
Reason 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 Terminated
Cyclophosphamide 840 MG / 250 ML NS IVPB
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Cyclophosphamide Monohydrate active pharmaceutical ingredient…
Reason 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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