Cyclophosphamide for Injection recall
FDA recall D-0433-2024 · initiated Apr 2, 2024
X-Gen Pharmaceuticals Inc. recalled Cyclophosphamide for Injection in Apr 2024 — an FDA Class III recall (D-0433-2024) because 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'.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was 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'.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1283 vials
Details
- 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.
- Recalling company
- X-Gen Pharms Inc
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Apr 2, 2024
- FDA report date
- Apr 10, 2024
Frequently asked
- Was Cyclophosphamide for Injection recalled?
- X-Gen Pharmaceuticals Inc. recalled Cyclophosphamide for Injection in Apr 2024 — an FDA Class III recall (D-0433-2024) because 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'. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Cyclophosphamide for Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0433-2024 was: 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'.
- Is a recalled Cyclophosphamide for Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cyclophosphamide for Injection are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot #: CIC1-23001 A, Exp. 08/30/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0433-2024.