CLASS I ONGOING Drug recall · Reported 12 Aug 2026 · FDA Enforcement Report
Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled
Sunny Pharmtech is recalling Cyclophosphamide for Injection, USP, One Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 17 Jul 2026 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0743-2026
- FDA event ID
- 99437
- Recalling firm
- Sunny Pharmtech, Taoyuan City
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 17 Jul 2026
- FDA classified
- 7 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Jul 2026 | Recall initiated by company | |
| 7 Aug 2026 | Classified by FDA | +21 days |
| 12 Aug 2026 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter; identified as stainless steel
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter; identified as stainless steel
Which lots are affected?
Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99437This product is part of a recall event; the main page for the event is Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled | Sunny Pharmtech | Particulate Matter | Nationwide |
More recalls from Sunny Pharmtech
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled | Sunny Pharmtech | Particulate Matter | Nationwide |
Other Cyclophosphamide recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cyclophosphamide for Injection, USP, One Single-Dose Vial recalled | Sunny Pharmtech | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Cyclophosphamide for Injection, USP, 500mg/vial recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Cyclophosphamide for Injection, USP, Lyophilized recalled | X-Gen Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Cyclophosphamide 840 MG / NS IVPB recalled by Infusion Options | Infusion Options | Sterility | NY |