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
sunny pharmtech recall notices matter most when the product is 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. The FDA classified it as Class I, the agency’s most serious category. That classification signals a reasonable probability of serious injury or death. If you or a family member received this chemotherapy drug, this guide explains what is known.
What the Sunny Pharmtech Recall Covers
The sunny pharmtech recall covers one specific injectable product. It is Cyclophosphamide for Injection, USP, 2 gram/vial, packaged as one single-dose vial. The product is Rx only. It is not sold in retail pharmacies to walk-in consumers. The listed NDC is 81298-8114-1.
The labeling adds important detail. The vials were manufactured for Long Grove Pharmaceuticals, LLC, of Rosemont, IL 60018. Manufacturing took place in Taiwan. Sunny Pharmtech Inc. is the recalling firm named in the FDA record. As a result, a hospital pharmacist may see more than one company name on the carton.
The scope of the sunny pharmtech recall is 1,464 units. That figure comes directly from the agency record. It is a modest number by pharmaceutical standards. However, unit counts do not measure risk. A Class I designation reflects potential severity, not volume.
Cyclophosphamide is a chemotherapy agent. Typically, it is administered in hospitals, infusion centers, and oncology clinics. Patients rarely handle the vials themselves. For example, a patient may only see the finished IV bag. In most cases, the recall will be handled at the facility level rather than by individuals.
The Hazard and Reported Injuries
The hazard in the sunny pharmtech recall is particulate matter. The FDA record identifies that particulate as stainless steel. Metal fragments have no place in an injectable drug. Injectable products are required to be essentially free of visible particles.
Particulate matter in an intravenous drug carries recognized medical concerns. Depending on size and quantity, particles may travel through the bloodstream. Clinicians generally worry about local irritation, vein injury, and blockage of small vessels. Immune reactions are another documented concern. Cyclophosphamide patients are often immunocompromised, which is why the FDA treats such contamination seriously.
The agency record does not state whether injuries have been reported. MassTortInfo.com will not claim that injuries occurred, and will not claim that none did. Neither statement is supported by the record. If the FDA updates the listing, the facts may change.
| Recall number | D-0744-2026 |
|---|---|
| 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
First, stop using any vial that matches the description. Set it aside and do not administer it. This applies to pharmacies, infusion centers, and clinical stockrooms. Individuals almost never hold these vials at home.
Next, verify identification carefully. Check the strength, the 2 gram/vial single-dose format, and the NDC 81298-8114-1. Also check for the Long Grove Pharmaceuticals labeling and the Sunny Pharmtech Inc. name. Documenting what you have makes the rest simpler.
The remedy instructions in the agency record did not match this product, so this guide does not state a remedy. That is a deliberate accuracy choice. Instead, follow the instructions in the official FDA notice linked on this page. Your facility’s pharmacy director or the distributor of record can also confirm the correct return or replacement process.
Patients should not panic or stop treatment on their own. In most cases, the safest step is a conversation with your oncology team. Ask whether your infusions used affected lots. Keep copies of infusion records, billing statements, and any adverse-event notes. Typically, those documents are the hardest to recover later.
Does a Sunny Pharmtech Recall Mean You Can Sue?
A recall is a safety action. It is not a lawsuit, and it is not a finding of legal fault. The sunny pharmtech recall means a product was pulled from distribution because of a defect. That is a regulatory step, taken by a company and overseen by the FDA.
A recall alone does not create a legal claim. Personal injury law generally requires more than a defective product existing somewhere. It usually requires an actual injury, plus proof that the specific product caused it. Lawyers call that second element causation, and it is often the hardest part.
For example, a patient who received an affected vial and then suffered a documented medical complication may have a stronger factual record. However, that is not automatic. Medical experts, treatment records, and lot tracing usually determine the outcome. Cancer patients also have complex baseline conditions, which makes causation analysis harder.
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If you believe you were harmed, you may be eligible to pursue a claim. Speak with a licensed attorney in your state. Deadlines called statutes of limitations apply, and they vary. Nothing here is legal advice, and no outcome or compensation is promised or implied.
How Recalls Connect to Mass Tort Cases
Recalls and mass torts are separate things that sometimes intersect. A recall notice can become documentary evidence in later litigation. It can show what a company knew, and when it acted. Plaintiffs’ lawyers often pair recall records with internal manufacturing documents.
History offers well-known examples. Philips recalled millions of CPAP and BiPAP devices in 2021 over degrading sound-abatement foam. That recall preceded consolidated federal litigation and a later settlement program. Takata’s airbag inflator recalls, among the largest in automotive history, similarly ran alongside years of litigation and a bankruptcy.
Those examples show a pattern, not a promise. Most recalls never produce mass tort litigation at all. As a result, readers should treat the sunny pharmtech recall as a safety notice today. MassTortInfo.com has not verified any lawsuit filed over this specific recall, and does not claim one exists.
Frequently Asked Questions
What product is affected by the sunny pharmtech recall?
Cyclophosphamide for Injection, USP, 2 gram/vial, in a single-dose vial, NDC 81298-8114-1. It is Rx only and was manufactured for Long Grove Pharmaceuticals, LLC, in Taiwan. The FDA recall number is D-0744-2026.
Why is this sunny pharmtech recall a Class I event?
Class I is the FDA’s most serious classification. It is used when there is a reasonable probability that a product will cause serious health consequences or death. Here, the stated hazard is stainless steel particulate matter in an injectable drug.
Were injuries reported in connection with the sunny pharmtech recall?
The FDA record does not state whether injuries have been reported. For that reason, this guide makes no claim in either direction. Check the official notice linked on this page for any updates.
How do I get a refund or replacement for recalled vials?
This guide does not state the remedy, because the remedy text in the agency record did not match this product. Follow the instructions in the official FDA notice linked on this page. Your pharmacy or distributor can confirm the correct process.
Does the sunny pharmtech recall mean I automatically have a case?
No. A recall is a safety action, not a lawsuit or an admission of liability. You may be eligible to pursue a claim if you suffered an injury and can show the product caused it, so consult a licensed attorney.
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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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.