Home/Recalls/FDA-D-0744-2026
FDA DrugsClass I

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

Published: August 12, 2026Recall ID: D-0744-2026Category: drugsCountry: US
US
PharmaceuticalFDA DrugsUSUS

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

Recalling Firm: Sunny Pharmtech Inc.

Reason for Recall / Hazard

Presence of Particulate Matter; identified as stainless steel

Product Description & Identification

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

Affected Products

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

Additional Source Details

FieldValue
CityTaoyuan City
Event id99437
Address 1Hsinchu Science Park
Address 2No. 255 Longyuan 1st Rd.; Longtan Dist.
Code infoLot # V24010V1, Exp 3/31/2027
Postal codeN/A
Report date20260812
Product typeDrugs
Product quantity1,464 vials
Reason for recallPresence of Particulate Matter; identified as stainless steel
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260717
Initial firm notificationLetter
Center classification date20260807

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Overview

  • Recalling FirmSunny Pharmtech Inc.
  • StatusOngoing
  • Risk LevelClass I
  • DistributionUSA Nationwide
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

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🚨 SAFETY ALERT: Sunny Pharmtech Inc. - 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

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