FDA posts nationwide recall of cyclophosphamide injections after steel particles found
The Food and Drug Administration published a nationwide recall of three lots of Sunny Pharmtech Inc. cyclophosphamide for injection on July 24, 2026, after steel particulate matter was identified in the product.
The recall covers 1-gram-per-vial and 2-gram-per-vial products and is being conducted to the user level. The action affects the facilities and professionals that receive, store or administer the drug, including pharmacies, hospitals and other health-care providers.
Cyclophosphamide is an injectable chemotherapy drug. The recall therefore creates an immediate product-control task for providers that use the medicine: They must determine whether affected product is in their inventories and follow the FDA-directed process for removing it from their operations.
What the recall requires
Under the recall strategy, pharmacies, hospitals and other providers were instructed to return affected product, reconcile their inventories and destroy the recalled product. Inventory reconciliation is intended to account for affected units and help facilities confirm that recalled product has been handled through the required process.
The recall notice identifies three lots and two vial strengths, but the approved FDA material does not state how many vials were distributed. It also does not identify the number of facilities that may have received the product or the number of patients who may have encountered it.
The recall was coordinated with Long Grove Pharmaceuticals and Cardinal Health. The FDA source identifies those companies as involved in notification and distribution coordination for the action.
What patients should know
The FDA directs patients who suspect a problem to contact a physician or other health-care provider. Patients should not stop prescribed treatment without medical advice.
That guidance is particularly important because the recalled product is an injectable chemotherapy drug, and treatment decisions may depend on a patient’s individual medical circumstances. The recall notice establishes instructions for handling the product; it does not direct patients to discontinue chemotherapy on their own.
The available FDA material does not report confirmed injuries linked to the steel particulate matter. The presence of a recall, by itself, should not be treated as a finding that a particular patient was harmed.
What is known about the action
Sunny Pharmtech announced the recall, and the FDA published the notice on July 24, 2026. The agency’s drug-recall listing also includes the cyclophosphamide action and confirms the stated reason: steel particulate matter identified in the product.
The recall is nationwide in the United States. Its user-level designation means the response is directed beyond a manufacturer or distributor alone and reaches the providers responsible for receiving and using the affected medicine.
The approved notice does not provide the source of the steel particles. It also does not provide a confirmed injury count, a patient count, a facility count or a total number of vials involved. Those figures cannot be inferred from the recall announcement.
What happens next
The next known step is implementation by providers. Facilities that handle cyclophosphamide must identify any affected product, coordinate its return, reconcile their records and destroy recalled inventory under the recall process.
Providers may also need to coordinate treatment-related decisions for patients whose care involves the affected product, including whether replacement treatment is needed. The approved material supports that practical consideration but does not announce a specific replacement-drug plan, supply update or patient deadline.
For patients, the FDA’s stated next step is to contact a physician or other health-care provider about any suspected problem. Patients should continue to rely on medical advice rather than stopping prescribed treatment independently. The notice does not announce a separate deadline for patients and does not report confirmed injuries associated with the recalled cyclophosphamide.
Sources
- Sunny Pharmtech Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, U.S. Food and Drug Administration
- Drug Recalls, U.S. Food and Drug Administration
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