Recall Summary
| Recall number | D-0580-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-06-17 |
| Company | SUN PHARMACEUTICAL INDUSTRIES INC |
| Units affected | 675 |
| 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
sun pharmaceutical recall notices reached a widely used cancer medication in June 2026. The U.S. Food and Drug Administration flagged a sterile injectable drug over safety concerns. The affected product is DOXOrubin Hydrochloride Liposome injection. It is a prescription chemotherapy medicine given by trained clinicians. The agency assigned this action its most serious risk classification. This matters because the drug goes directly into a patient’s body. As a result, patients, caregivers, and pharmacy staff should understand what happened. This guide explains the recall in plain language.
What the Sun Pharmaceutical Recall Covers
The recall involves a single, specific drug product. It is DOXOrubin Hydrochloride Liposome injection. The strength is 50 mg per 25 mL, or 2 mg/mL. It ships in 25 mL single-dose vials. The label reads “Sterile” and “Rx only.” Each vial carries the National Drug Code 72603-200-01. These details help pharmacies confirm whether they hold recalled stock.
The product was manufactured for Northstar Rx LLC of Memphis, Tennessee. However, the actual maker was Sun Pharmaceutical Ind. Ltd. That facility sits on the Halol-Baroda Highway in Halol, Gujarat, India. This sun pharmaceutical recall therefore crosses a global supply chain. In most cases, injectable drugs pass through several handlers before reaching a hospital.
The FDA logged this action under recall number D-0580-2026. The recall date is June 17, 2026. The scope covers 675 units. Because this is a prescription hospital drug, consumers rarely handle it directly. Typically, oncology pharmacies and infusion centers stock this kind of medication. For example, a hospital pharmacy would store and dispense it under strict controls.
Doxorubicin liposome injection is a chemotherapy agent. Clinicians use it to treat certain cancers. It is not sold over the counter. As a result, the people most affected are patients receiving infusions and the staff who prepare them. This sun pharmaceutical recall focuses attention on that specific setting.
The Hazard and Reported Injuries
The FDA identified a clear physical hazard. Inspectors found particulate matter inside the product. The agency identified that particulate matter as glass. Glass fragments in an injectable drug are a serious concern. This medicine is delivered into the bloodstream. Therefore, foreign particles can travel through the body.
The agency gave this a Class I classification. That is the most severe recall category the FDA uses. A Class I recall means there is a reasonable chance the product could cause serious harm or death. However, that describes the risk level, not a confirmed outcome. The classification reflects potential danger, not a count of victims.
The official record does not state whether any injuries occurred. As a result, this guide will not claim that injuries happened. It will also not claim that none did. We simply follow the agency record. In most cases, recall notices classify risk before all outcomes are known.
| Recall number | D-0580-2026 |
|---|---|
| Issuing agency | U.S. Food and Drug Administration |
| Recall date | June 17, 2026 |
| Company | Sun Pharmaceutical Industries Inc |
| Units affected | 675 units |
| Severity | Class I |
What To Do If You Own This Product
Start by identifying the product carefully. Check the drug name, strength, and vial size. Look for NDC 72603-200-01 on the label. Also look for the Northstar Rx and Sun Pharmaceutical manufacturer text. If a lot matches, set it aside. Do not use a recalled injectable drug.
This is a hospital and pharmacy product, not a home medicine. Therefore, most consumers will never handle it. If you are a patient, you do not need to search your home. Instead, talk to your oncology team. Ask whether your treatment used any affected stock. In most cases, your care team will already have this information.
For the exact return or replacement steps, follow the official notice. The agency record for this recall contains remedy text that does not match the product. For that reason, the specific remedy has been withheld here. Do not rely on secondhand instructions. Instead, use the instructions in the official FDA notice linked on this page.
Pharmacy and infusion staff should act promptly. Quarantine any matching vials right away. Then contact the distributor for guidance. Document what you find, including lot details and quantities. As a result, your facility keeps a clear record. This sun pharmaceutical recall requires careful handling at the pharmacy level.
Does a Sun Pharmaceutical Recall Mean You Can Sue?
A recall is a safety action. It is not a lawsuit. These are two very different things. A sun pharmaceutical recall means a company or agency pulled a product to prevent harm. It does not, by itself, prove that anyone was hurt. Therefore, a recall alone is not a legal claim.
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To have a claim, more is usually needed. Typically, a person must show an actual injury. They must also connect that injury to the product. Lawyers call that link “causation.” Without both an injury and causation, a recall does not create a case. For example, a matching vial with no harm is not a claim.
If you believe this product harmed you, seek medical care first. Then keep your records. After that, you may consult a licensed attorney. An attorney can review your facts and explain your options. You may be eligible to pursue a claim in some situations. However, no one can promise money or a specific result.
Be cautious with anyone who guarantees compensation. Honest professionals do not do that. A sun pharmaceutical recall does not entitle anyone to payment. It simply signals a safety problem. As a result, each situation must be judged on its own facts by a qualified lawyer.
How Recalls Connect to Mass Tort Cases
Recalls and lawsuits can overlap over time. A recall documents that a product had a defect. Later, that record can become evidence. However, the recall itself is only one piece. Plaintiffs still must prove injury and causation. For example, the Takata airbag recalls preceded large litigation and a global safety crisis.
The Philips CPAP recall followed a similar path. Philips recalled breathing machines over a foam breakdown concern. That recall then supported later mass tort claims by users. In most cases, the recall provides a factual starting point. Typically, though, courts still require independent proof of harm. A sun pharmaceutical recall would follow those same legal rules.
Frequently Asked Questions
What product is affected by this sun pharmaceutical recall?
The recall covers DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL. It ships in 25 mL single-dose vials under NDC 72603-200-01. It is a prescription-only chemotherapy medicine.
Why was the drug recalled?
The FDA found particulate matter identified as glass in the product. Glass in an injectable drug is a serious safety hazard. The agency gave it a Class I classification, its most severe level.
Does this recall mean I have a lawsuit?
No. A recall is a safety action, not a lawsuit. A claim usually needs an actual injury plus causation. Speak with a licensed attorney to review your specific situation.
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 July 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.