Food, drugs, devices › X-Gen Pharmaceuticals Inc.
Drug recall: Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx
FDA enforcement event 94348 is a drug recall by X-Gen Pharmaceuticals Inc. of Horseheads, NY, initiated 2 Apr 2024 and classified Class III, with 2 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 15% of the 319 drug enforcement events initiated in 2024 carry the same class.
Status: Terminated, terminated 30 Sep 2025. Initiation: voluntary: firm initiated. X-Gen Pharmaceuticals Inc. has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
X-Gen Pharmaceuticals Inc., Horseheads, NY.
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'."
Distribution
"Nationwide in the US"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0433-2024 | 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. | 1283 vials | Class III | Terminated | 10 Apr 2024 |
| D-0434-2024 | Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC #… | 1332 vials | Class III | Terminated | 10 Apr 2024 |
Context
Other enforcement events for X-Gen Pharmaceuticals Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Mar 2021 | Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. | Drug | Class II | 1 |
| 11 Oct 2019 | Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limit | Drug | Class III | 1 |
| 29 Mar 2019 | Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceut | Drug | Class III | 1 |
| 17 May 2017 | Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61 | Drug | Class II | 1 |
| 8 Feb 2017 | Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single | Drug | Class I | 1 |
| 17 Jul 2014 | Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceut | Drug | Class III | 1 |
All 7 events for X-Gen Pharmaceuticals Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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'."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the US"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Sep 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.