Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error
X-Gen Pharmaceuticals is recalling 1,283 vials of Cyclophosphamide for Injection due to a Package Insert error that lists concentration as '20 mg per vial' instead of '20 mg per mL'. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III labeling error with no reported illnesses or injuries. While incorrect concentration labeling on a cytotoxic injectable poses risk for dosing errors in a professional healthcare context, no actual harm has occurred. Class III recalls with theoretical-only hazards score as Moderate per the severity rubric.
Plain-English summary
X-Gen Pharmaceuticals Inc. is recalling 1,283 vials of Cyclophosphamide for Injection, USP (500 mg/vial, lyophilized, for intravenous use). The affected lot is #CIC1-23001 A with expiration date 08/30/2026 (NDC # 39822-0250-01). Distribution was nationwide in the United States.
The recall was initiated due to an error in the Package Insert, section 2.3 (Preparation, Handling, and Administration). The concentration of the reconstituted product is incorrectly listed as '20 mg per vial' when the correct statement should read '20 mg per mL'. This labeling discrepancy could lead to incorrect dose calculations by healthcare providers preparing or administering the injection.
Cyclophosphamide is a prescription cytotoxic injectable administered exclusively in healthcare settings. Healthcare providers should immediately cease use of affected vials and contact X-Gen Pharmaceuticals for replacement product or information. No illnesses or injuries have been reported in connection with this labeling error.
The recalled product
- Product
- 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.
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Category
- Drug — Chemotherapy / Injectable
- Affected units
- 1,283
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: CIC1-23001 A
- Exp. 08/30/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by X-Gen Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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