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CriticalRecall #D-0744-2026Drug / Pharmaceutical

Sunny Pharmtech Inc. Recalls Cyclophosphamide for Injection

Sunny Pharmtech Inc. · Class I — Most Serious

Assorted pharmaceutical pills and tablets — representative photo for FDA drug recall
An assortment of pharmaceutical pills (representative file photo). Specific recalled product: see recall details below. Photo: Michael Nutt / Wikimedia Commons (CC BY-SA 2.0).

Product Description

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

FDA Classification

Class I — Most Serious

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.

Distribution

USA Nationwide

Remedy

Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.

411 Press Analysis

A Class I recall — the FDA's most urgent classification — has been issued for a pharmaceutical product recalled by Sunny Pharmtech Inc. on July 17, 2026. Presence of Particulate Matter; identified as stainless steel. This recall affects 1,464 vials and was distributed in USA Nationwide. Class I recalls indicate a reasonable probability of serious health consequences or death. Consumers should stop using this product immediately.

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