FDA recall D-0744-2026

Sunny Pharmtech Inc. · Class I · drug

Product

Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1

Reason for recall

Presence of Particulate Matter; identified as stainless steel

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2026-07-17
Report date
2026-08-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Taoyuan City, Taiwan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0744-2026