Cyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error
X-Gen Pharmaceuticals recalls Cyclophosphamide for Injection due to a labeling error in the Package Insert. Section 2.3 incorrectly lists the concentration as '20 mg per vial' instead of the correct '20 mg per mL'.
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 recall involving a labeling error without reported illnesses or injuries. Per the rubric, Class III recalls typically score 1 or 2, and theoretical hazards without reported harm are capped at score 3. The concentration mislabeling on a chemotherapy package insert justifies a Moderate score.
Plain-English summary
X-Gen Pharmaceuticals Inc. is recalling Cyclophosphamide for Injection, USP, 1g/vial with Lot #CIC2-23001 A and expiration date 11/30/2026. A total of 1,332 vials have been distributed nationwide in the United States.
The product is a single dose vial containing cyclophosphamide as a lyophilized (freeze-dried) powder that must be reconstituted before intravenous administration. Cyclophosphamide is a cytotoxic chemotherapy agent used in cancer treatment.
The recall was initiated due to a labeling error in the Package Insert. Section 2.3 'Preparation, Handling, and Administration' incorrectly lists the concentration of the reconstituted product as '20 mg per vial' when it should read '20 mg per mL'.
The recalled product
- Product
- 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…
- Manufacturer
- X-Gen Pharmaceuticals Inc.
- Category
- Drug — Injectable Chemotherapy
- Hazard
- Affected units
- 1,332
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 #: CIC2-23001 A
- Exp. 11/30/2026
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.
See all 2 products in this recall →Related recalls
Same manufacturer · X-Gen Pharmaceuticals Inc.
See all →- ModerateCyclophosphamide Injection Recalled for Package Insert Concentration Labeling Error
FDA (Drugs) · 2024-04-10
- ModerateX-Gen Recalls Neomycin Sulfate Tablets Due to Microbiological Failure
FDA (Drugs) · 2021-04-14
- LowX-Gen Pharmaceuticals Recalls Levetiracetam Injection Due to Incorrect Package Insert
FDA (Drugs) · 2019-11-27
- ModerateX-Gen Recalls Clonidine Injection Vials Due to Labeling Error
FDA (Drugs) · 2019-04-17
- ModerateX-Gen Recalls Nystatin Topical Powder Due to Potential Plastic Particles
FDA (Drugs) · 2017-08-16
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateHealthmark Vinyl Instrument Guards Recalled for Labeling Non-Compliance
FDA (Devices) · 2026-10-21
- ModerateGore Viabil Short Wire Biliary Endoprosthesis Recalled for Incorrect Length Labeling
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
Similar recalls
- SevereCyclophosphamide Injection Recall: Stainless Steel Particulate Matter Found
FDA (Drugs) · 2026-08-12
- CriticalCyclophosphamide Injection Recalled Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-08-12
- LowX-Gen Recalls Clonidine HCl Injection Due to Labeling Error
FDA (Drugs) · 2014-07-30
- ModerateX-Gen Recalls Clonidine Injection Vials Due to Labeling Error
FDA (Drugs) · 2019-04-17
- ModerateCyanocobalamin Injection Recalled Due to Subpotency and Assay Non-Compliance
FDA (Drugs) · 2022-05-04
- LowSanofi Recalls Clofarabine Injection Vials Due to Incorrect Package Insert
FDA (Drugs) · 2017-11-08