Recall Summary
| Recall number | D-0800-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-08-26 |
| Company | American Regent, Inc. |
| Units affected | 86,100 |
| 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
american regent recall notices matter because injectable drugs go straight into the body. On August 26, 2026, the U.S. Food and Drug Administration listed recall number D-0800-2026. It covers Papaverine HCl Injection, USP, 60 mg/2 mL, made by American Regent, Inc. of Shirley, NY. The FDA classified it Class I, the most serious level. The reason is particulate matter identified as glass and/or paraformaldehyde. About 86,100 units fall within the scope.
What the American Regent Recall Covers
The recalled drug is Papaverine Hydrochloride Injection, USP. The strength is 60 mg per 2 mL, which equals 30 mg/mL. It is a prescription-only product, marked Rx Only on the labeling. Papaverine is a vasodilator used in clinical settings, not a consumer over-the-counter medicine.
Two package configurations are named in the american regent recall record. The first is a 2 mL Single-Dose Vial, NDC 0517-4002-01. The second is a carton of 25 x 2 mL Single-Dose Vials, NDC 0517-4002-25. The NDC number is the fastest way to confirm a match. It appears on the vial label and on the outer carton.
The labeled manufacturer is American Regent, Inc., Shirley, NY 11967. Because this is an Rx product, most affected units sit in hospitals, surgical centers, clinics, and pharmacies. For example, a hospital pharmacy may hold several cartons at once. In most cases, patients never handle the vial themselves.
The agency record does not publish a lot-code list in the summary shown here. However, the official notice linked on this page is the controlling source for lot-level detail. Typically, distributors receive direct written notification as well. If your facility received either NDC, check stock before assuming you are clear.
The Hazard and Reported Injuries
The stated hazard is presence of particulate matter. The FDA record identifies the particulate as glass and/or paraformaldehyde. Glass particles can enter a vial when the container is damaged or breaks during processing. Paraformaldehyde is a chemical residue that should not be present in an injectable drug.
Particulate matter in an injection is treated seriously by regulators. An injected particle bypasses the body’s normal filters. As a result, it can travel through the bloodstream. Depending on size and location, particles may cause local irritation, vessel blockage, or an immune response. That risk is the basis for the Class I designation.
Class I is the FDA’s most serious recall category. It means there is a reasonable probability that use of the product will cause serious adverse health consequences or death. However, a Class I classification describes potential risk. It is not a finding that any specific patient was harmed.
Whether injuries have been reported in connection with this recall is not stated in the agency record. This guide will not claim harm occurred, and it will not claim harm did not occur. Readers with health concerns should speak to a clinician rather than rely on any website. Below is the core record for the american regent recall.
| Recall number | D-0800-2026 |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Date | August 26, 2026 |
| Company | American Regent, Inc., Shirley, NY 11967 |
| Product | Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL) |
| NDC numbers | 0517-4002-01; 0517-4002-25 |
| Units affected | 86,100 |
| Severity | Class I |
What To Do If You Own This Product
The first step is simple. Stop using any vial that matches the recalled description. Quarantine the stock so it cannot be pulled by mistake. In a clinical setting, that usually means physically separating the product from active inventory and labeling it clearly.
Next, confirm identification. Read the NDC on the vial and on the carton. Compare it to 0517-4002-01 and 0517-4002-25. Also confirm the product name, the strength of 60 mg/2 mL, and the American Regent label. If any element does not match, the unit may fall outside the american regent recall.
For the remedy, follow the instructions in the official notice linked on this page. This guide does not state the return, replacement, or refund process. The agency record’s remedy language did not match this product, so it is not repeated here. Typically, the manufacturer’s direct notification to customers explains exactly what to do with affected stock.
Patients are in a different position than facilities. If you believe you received this drug during a procedure, contact the treating provider. Ask whether recalled lots were used and what follow-up, if any, is advised. However, do not stop prescribed treatment on your own. Suspected adverse events can also be reported to the FDA’s MedWatch program.
Does a American Regent Recall Mean You Can Sue?
A recall is a safety action. It is not a lawsuit. When a company pulls a product, it is correcting a distribution problem under agency oversight. That step does not create a legal claim by itself, and it does not mean money is owed to anyone.
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Civil claims generally require more than a recall notice. In most cases, a person must show an actual injury. They must also show that the specific defective product caused that injury. Causation is often the hardest part, especially with drugs given during complex medical care.
An american regent recall record can still be useful evidence. It documents what the FDA identified, when, and at what severity level. For example, it establishes that a particulate contamination issue existed in a defined product line. However, evidence of a defect is not the same as proof that a defect harmed a particular patient.
If you were treated with this product and believe you were injured, talk to a licensed attorney in your state. An attorney can review your medical records and the applicable deadlines. You may be eligible to pursue a claim. No outcome is guaranteed, and nothing on this page is legal advice.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become the starting point for larger litigation. The Philips CPAP and BiPAP recall in 2021 is a well-known example. Philips recalled millions of sleep and ventilator devices over degrading sound-abatement foam. Thousands of claims were later consolidated into multidistrict litigation, and the recall record featured heavily in that history.
The Takata airbag inflator recalls followed a similar arc. Massive automotive recalls preceded and accompanied years of claims and regulatory action. In both examples, the recall documents helped show what a company knew and when it acted. Typically, plaintiffs’ lawyers use recall records to frame notice and defect questions.
That pattern does not mean litigation follows every recall. Most recalls end with corrected inventory and no lawsuits at all. As of this writing, this guide does not assert that any lawsuit exists over the american regent recall described here. The record above is a regulatory action, and it should be read that way.
Frequently Asked Questions
What product is covered by the american regent recall?
It covers Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), in 2 mL single-dose vials. The NDC numbers are 0517-4002-01 and 0517-4002-25. The recall number is D-0800-2026.
Why is this an american regent recall classified as Class I?
The FDA cited particulate matter identified as glass and/or paraformaldehyde in the product. Class I is used when there is a reasonable probability of serious health consequences or death. It reflects potential risk, not a confirmed injury count.
How do I get the remedy under this american regent recall?
Follow the instructions in the official notice linked on this page. This guide does not restate the remedy, because the agency record’s remedy text did not match this product. Facilities should also watch for direct notification from the manufacturer or distributor.
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 September 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.