FDA Drugs recall ·
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0743-2026
- Date
- (initiated July 17, 2026)
- Company / brand
- Sunny Pharmtech Inc.
Hsinchu Science Park, Taoyuan City, Taiwan - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 4,077 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
Why was it recalled?
Presence of Particulate Matter; identified as stainless steel
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027
Distribution
USA Nationwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0743-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.