Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceut
Summary
The FDA issued a Class I for Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, by Sunny Pharmtech Inc.. Reason: Presence of Particulate Matter; identified as stainless steel.
Details
Source
Drug Recall
External ID
D-0743-2026
Action Date
2026-08-12
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027
Quantity Affected: 4,077 vials
Reason for Recall
Presence of Particulate Matter; identified as stainless steel
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-17
Company
Taoyuan City
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 11 drug recalls issued in the same week, part of 59 drug-related FDA actions this month.
Sunny Pharmtech Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sunny Pharmtech Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sunny Pharmtech Inc. have FDA actions?
Sunny Pharmtech Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0743-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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