Multi-event July 2026 FDA Recall Drug by Sunny Pharmtech Inc.

This Multi-event Class I drug recall was voluntarily initiated by Sunny Pharmtech Inc. on July 17, 2026 for the product Drug. The FDA reported the reason for recall as presence of particulate matter; identified as stainless steel. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

D-0744-2026 ONGOING D-0743-2026 ONGOING

Recall Number: D-0744-2026

Reason for Recall
Presence of Particulate Matter; identified as stainless steel
Initiated
07-17-2026
Reported
08-12-2026
Quantity
1,464 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99437
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sunny Pharmtech Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# V24010V1, Exp 3/31/2027

Recall Number: D-0743-2026

Reason for Recall
Presence of Particulate Matter; identified as stainless steel
Initiated
07-17-2026
Reported
08-12-2026
Quantity
4,077 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99437
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sunny Pharmtech Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027