CLASS III Drug recall · Reported 10 Apr 2024 · FDA Enforcement Report
Cyclophosphamide for Injection, USP, 500mg/vial recalled
X-Gen Pharmaceuticals is recalling Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single, distributed nationwide in the US. The recall was initiated on 2 Apr 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0433-2024
- FDA event ID
- 94348
- Recalling firm
- X-Gen Pharmaceuticals, Horseheads, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Apr 2024
- FDA classified
- 4 Apr 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Apr 2024 | Recall initiated by company | |
| 4 Apr 2024 | Classified by FDA | +2 days |
| 10 Apr 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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'.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
Where it was distributed
Nationwide in the US
Questions about this recall
Is Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single recalled?
Yes. X-Gen Pharmaceuticals recalled Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single on 2 Apr 2024. The recall is Class III and its status is Terminated. Recall number D-0433-2024.
Why was it recalled?
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'.
Which lots are affected?
Lot #: CIC1-23001 A, Exp. 08/30/2026
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from X-Gen Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cyclophosphamide for Injection, USP, Lyophilized recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Neomycin Sulfate Tablets, USP 500mg recalled by X-Gen Pharmaceuticals | X-Gen Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Levetiracetam Injection, 500 mg/-use vials recalledLevetiracetam | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Clonidine HCL Injection, 1000 mcg/ (100 mcg/mL) Single Dose Vial recalledClonidine | X-Gen Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Nystatin Topical Powder, USP, 100,000 USP units per gram recalled | X-Gen Pharmaceuticals | Particulate Matter | Nationwide |
Other Cyclophosphamide recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled | Sunny Pharmtech | Particulate Matter | Nationwide |
| Drug | CLASS I | Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled | Sunny Pharmtech | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Sterility | Nationwide |
| Drug | CLASS III | Cyclophosphamide for Injection, USP, Lyophilized recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |