FDA-Drug2026-08-12Class IPROCESSING DEFECT
Sunny Pharmtech Cyclophosphamide for Injection recalled for stainless steel particulate matter
What this means
Cyclophosphamide for Injection, USP (1 gram/vial) manufactured by Sunny Pharmtech Inc. for Long Grove Pharmaceuticals may contain stainless steel particulate matter. The contamination was identified in two specific lots before distribution was completed.
- If you have received vials from Lot # C23019V1 (Exp 10/31/2026) or Lot # C24015V1 (Exp 4/30/2027), do not use them.
- Contact your pharmacy or hospital to verify whether you received affected product.
- Consult your physician or pharmacist about next steps for your treatment.
The agency's original wording
Hazard
Presence of Particulate Matter; identified as stainless steel
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
4,077 vials
Manufactured in
Hsinchu Science Park, No. 255 Longyuan 1st Rd.; Longtan Dist., Taoyuan City, Taiwan
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0743-2026More Sunny Pharmtech recalls
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