Lower risk Drug recall · FDA · Published April 2, 2024

X-Gen Cyclophosphamide Injection: Incorrect Labeling May Cause Dosage Errors

X-Gen Pharmaceuticals recalls Cyclophosphamide injection vials due to incorrect labeling that could lead to improper dosing. Discard unused solution if you have the specific lot number.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0434-2024Drug X-Gen Pharmaceuticals ›

Lower-risk 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'.

Take action

Contact the company

Recalling firmX-Gen Pharmaceuticals Inc.300 Daniel Zenker Dr · Horseheads, NY 14845-1014

✎ GovInfoNow plain-language explainer

X-Gen Pharmaceuticals is recalling a specific type of cyclophosphamide injection vial because the package insert incorrectly states the concentration as '20 mg per vial' instead of '20 mg per mL'. This could lead to incorrect dosing if the product is used without proper dilution. Read more at govinfonow.com/recall/32749-x-gen-cyclophosphamide-injection-incorrect-labeling-may-cause-dosage-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/32749-x-gen-cyclophosphamide-injection-incorrect-labeling-may-cause-dosage-errors · Updated August 17, 2026 · FDA enforcement record: FDA #D-0434-2024

Cite this page

“X-Gen Cyclophosphamide Injection: Incorrect Labeling May Cause Dosage Errors.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32749-x-gen-cyclophosphamide-injection-incorrect-labeling-may-cause-dosage-errors. Based on FDA recall #D-0434-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0434-2024%22&limit=1).

The FDA announced on April 2, 2024, that X-Gen Pharmaceuticals Inc. is recalling Cyclophosphamide for Injection due to labeling errors in the Package Insert. The company stated the recall is voluntary and has been terminated.

How to tell if you have it

Brand: X-Gen Pharmaceuticals
Product: Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial
NDC #: 39822-0255-01
Lot #: CIC2-23001 A
Expiration: 11/30/2026

The hazard

The Package Insert, section 2.3, incorrectly lists the concentration of the reconstituted product as '20 mg per vial' instead of the correct '20 mg per mL'. This error could lead to improper administration of the cytotoxic agent.

Context

GovInfoNow's records show X-Gen Pharmaceuticals Inc. has had six other recalls since July 17, 2014, including labeling errors for Levetiracetam Injection on Oct. 11, 2019, and Clonidine Injection on March 29, 2019. Other recent recalls of similar products include Otsuka ICU Medical Potassium Chloride Inj. 20mEq Label Error Recall (Oct. 29, 2025), Slate Run Recalls Eptifibatide Injection Due to Labeling Error (Feb. 12, 2026), and Safecor Atomoxetine Capsules 10mg Mislabeled as 25mg - Label Error (April 30, 2026).

How to tell if you have this one

Check for the vial labeled 'Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial' with lot number CIC2-23001 A. The product is a cytotoxic agent requiring a prescription.

Brand
X-Gen Pharmaceuticals
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
Nationwide in the US

Recall number	Product, codes & lots	Quantity
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.; Lot #: CIC1-23001 A, Exp. 08/30/2026	1283 vials
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 # 39822-0255-01.; Lot #: CIC2-23001 A, Exp. 11/30/2026	1332 vials

Based on the official FDA remedy

What to do — step by step

Check Vial Label
Look for the lot number CIC2-23001 A on the vial.
Discard Unused Solution
If you have the specific vial with lot number CIC2-23001 A, discard the unused solution immediately.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

Apr 2, 2024Firm started the recall
Apr 4, 2024FDA classified it Class III
Apr 10, 2024Published in FDA’s Enforcement Report
Sep 30, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

This product is safe to use only if the concentration is correctly understood and the product is properly diluted as per the updated instructions.

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Link to this recall

<a href="https://govinfonow.com/recall/32749-x-gen-cyclophosphamide-injection-incorrect-labeling-may-cause-dosage-errors">X-Gen Cyclophosphamide Injection: Incorrect Labeling May Cause Dosage Errors (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0434-2024 (April 2, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0434-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.