Cyclophosphamide for Injection Recall: What To Do

Recall Summary

Recall number D-0744-2026
Issued by U.S. Food and Drug Administration
Date 2026-08-12
Company Sunny Pharmtech Inc.
Units affected 1,464
Severity Class I

Remedy: Follow the instructions in the official notice linked below. The agency record for this recall did not contain remedy text we could verify against this product, so we have not reproduced it here.

Read the official U.S. Food and Drug Administration recall notice

The sunny pharmtech recall is a Class I action involving an injectable cancer drug. On August 12, 2026, the U.S. Food and Drug Administration listed recall number D-0744-2026. It covers Cyclophosphamide for Injection, USP, 2 gram/vial, made by Sunny Pharmtech Inc. The reason is particulate matter identified as stainless steel. Class I is the FDA’s most serious category. It signals a reasonable probability of serious harm or death. As a result, patients, caregivers, and pharmacy staff should read the official notice closely.

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What the Sunny Pharmtech Recall Covers

The recalled item is Cyclophosphamide for Injection, USP, 2 gram/vial. It ships as one single-dose vial. It is an Rx only product. The label lists NDC 81298-8114-1. The product was manufactured for Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. It was manufactured in Taiwan. Sunny Pharmtech Inc. is the recalling firm named in the FDA record.

The scope is 1,464 units. That figure comes directly from the agency record. Cyclophosphamide is a chemotherapy drug. It is not sold in retail stores. In most cases, it reaches patients through hospitals, infusion centers, and oncology clinics. Typically, a pharmacist reconstitutes the vial before a nurse administers it.

Consumers rarely handle these vials themselves. However, patients still have a stake in the sunny pharmtech recall. Your infusion may have come from an affected lot. Facilities are the parties expected to check inventory and quarantine stock. Ask your treatment center whether it received product under NDC 81298-8114-1.

Additional lot codes and expiration dates may appear in the FDA enforcement listing. The sunny pharmtech recall entry is the controlling source for those identifiers. For example, the vial carton and the label both carry the NDC. Match those details before drawing any conclusion about your own treatment.

The Hazard and Reported Injuries

The stated hazard is the presence of particulate matter. The FDA record identifies that particulate as stainless steel. Metal particles in an injectable product are a recognized safety concern. This drug is given intravenously. As a result, anything in the vial can enter the bloodstream directly.

Medical literature describes general risks from injected particulates. These can include local vein irritation and inflammatory responses. Particles may also travel through the circulatory system. Patients receiving chemotherapy are often already medically fragile. Typically, that reduces their margin for any added complication. That context helps explain the Class I designation.

The agency record does not state whether injuries occurred. MassTortInfo.com will not claim that injuries happened. We also will not claim that none happened. Neither statement is supported by the document. However, the severity classification speaks to potential harm, not to confirmed harm.

The table below summarizes the core facts of the sunny pharmtech recall.

Recall number D-0744-2026
Issuing agency U.S. Food and Drug Administration
Recall date August 12, 2026
Company Sunny Pharmtech Inc.
Product Cyclophosphamide for Injection, USP, 2 gram/vial, NDC 81298-8114-1
Hazard Presence of particulate matter; identified as stainless steel
Units affected 1,464
Severity classification Class I

What To Do If You Own This Product

Stop using any vial matching the recalled description. This step applies mainly to pharmacies and clinics. Quarantine the stock so no one administers it by mistake. Do not attempt to filter or inspect the vial and then use it. Visual inspection is not a reliable substitute for a formal recall response.

Identify the product by its label details. Look for Cyclophosphamide for Injection, USP, 2 gram/vial. Confirm NDC 81298-8114-1. Check for the “Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018” line. Note that the product was manufactured in Taiwan. Record the lot number and expiration date before taking further action.

We are not stating the remedy here. The remedy text in the agency record does not match this product. Rather than guess, follow the instructions in the official notice. You can read the FDA enforcement listing here: FDA Enforcement Report — drug recalls. That notice governs returns, replacement, and any required paperwork.

Patients should talk with their oncology team. Ask whether your infusion used product covered by the sunny pharmtech recall. Ask what the facility did with affected inventory. If you feel unwell, seek medical care first. You can also report a problem to FDA MedWatch. Keep copies of your infusion records and any billing statements.

Does a Sunny Pharmtech Recall Mean You Can Sue?

A recall is a safety action. It is not a lawsuit. The sunny pharmtech recall is a regulatory event under FDA oversight. It removes product from the supply chain. It does not, by itself, establish that anyone was hurt. It also does not create an automatic right to money.

Legal claims generally require more than a defect notice. In most cases, a plaintiff must show an actual injury. They must also show that the specific product caused that injury. That link is called causation. Documentation matters, including treatment records and product identifiers. Without those pieces, a recall alone is not a claim.

You may be eligible to pursue a claim if you were injured. That is a conditional statement, not a promise. No one can tell you that you are owed compensation. Deadlines called statutes of limitations also apply and vary by state. As a result, waiting can quietly close the door on options.

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Talk with a licensed attorney in your state. Choose one who handles pharmaceutical and product liability matters. Many offer free consultations. Bring your infusion records, vial information, and the recall number. This article is general education, not legal advice. Nothing here guarantees any outcome.

How Recalls Connect to Mass Tort Cases

Recalls often become evidence in later litigation. They can show that a defect existed. They can also show when a company learned about it. Plaintiffs’ lawyers frequently use recall notices to build timelines. Defense lawyers use them too, sometimes to argue prompt corrective action. However, a recall document is only one piece of a much larger record.

History offers well-known examples. The Philips CPAP recall in 2021 involved sound-abatement foam degradation. It later grew into consolidated federal litigation. The Takata airbag inflator recalls became one of the largest automotive recalls ever. That matter also produced extensive litigation and a bankruptcy. For example, internal testing documents often matter more than the recall notice itself.

Those examples do not predict anything about this drug recall. We are not aware of verified litigation over the sunny pharmtech recall. Typically, litigation depends on injury patterns that emerge over time. In most cases, that takes months or years. Readers should watch official FDA updates rather than rumor.

Frequently Asked Questions

What product is covered by the sunny pharmtech recall?

The recall covers Cyclophosphamide for Injection, USP, 2 gram/vial, one single-dose vial, Rx only. It carries NDC 81298-8114-1. It was manufactured for Long Grove Pharmaceuticals, LLC, in Taiwan.

Why is this recall classified as Class I?

Class I is the FDA’s most serious recall class. It applies when there is a reasonable probability that use could cause serious injury or death. Here, the hazard is stainless steel particulate matter in an injectable drug.

Have injuries been reported in this recall?

The agency record does not state whether injuries were reported. We will not claim injuries occurred or that none occurred. Check the official FDA enforcement listing for any updates.

How do I get the remedy for the sunny pharmtech recall?

Follow the instructions in the official notice linked on this page. The remedy details are not restated here because the agency record contains mismatched remedy text. Your pharmacy or supplier can also confirm the correct process.

Does the sunny pharmtech recall mean I have a lawsuit?

No. A recall is a safety action, not a legal claim. You may be eligible to pursue a claim if you suffered an injury linked to the product, but only a licensed attorney can evaluate that.

Were You Injured by a Recalled Product?

A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.

Official Sources & Resources

Verify every recall against the issuing agency before acting:

  • U.S. Food and Drug Administration: official recall database — the record of truth for this notice
  • CPSC: cpsc.gov — household goods, toys, furniture, appliances
  • FDA: fda.gov — food, drugs, and medical devices
  • NHTSA: nhtsa.gov — vehicles, tires, and child car seats
  • USDA FSIS: fsis.usda.gov — meat, poultry, and egg products

Content last reviewed August 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.

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