FDA Posts Nationwide Recall of Papaverine Injection After Visible Particles Found

The FDA has posted a nationwide recall of one lot of American Regent Papaverine Hydrochloride Injection, USP, after visible particulate matter identified as glass and/or paraformaldehyde was found in the injectable prescription drug.

American Regent announced the voluntary recall on July 24, 2026. The FDA published its notice on July 27. The affected product was distributed across the United States beginning September 30, 2025, so hospitals, clinics and other health-care facilities should check their inventories.

How to identify the recalled product

The recall covers only the following product and lot:

• Product: Papaverine Hydrochloride Injection, USP, 60 mg/2 mL
• Format: Single-dose vial
• NDC: 0517-4002-25
• Lot: 25202
• Expiration date: November 30, 2026

The recall does not cover every papaverine injection, every American Regent product or every lot of this medication. Facilities should match the product’s NDC, lot number and expiration date before taking action.

Why the injection was recalled

According to the FDA notice, the particulate matter was identified as glass and/or paraformaldehyde. The agency warns that injecting a product containing particles may cause local irritation or swelling. Particles could also travel through blood vessels to the heart, lungs or brain, potentially causing stroke or death.

The FDA describes those outcomes as potential risks associated with injected particulate matter. American Regent said it had received no related adverse-event reports as of July 24, 2026. That statement does not mean patients should ignore possible symptoms or change treatment without medical advice.

What health-care facilities should do

Hospitals, clinics, procedural settings, pharmacies and other health-care facilities that may have the affected vials should stop using them and isolate the product. American Regent’s instructions call for recalled product to be returned or discarded according to the company’s directions. Facilities should follow the manufacturer’s return, replacement or disposal instructions rather than placing affected vials back into routine inventory.

Papaverine injection is administered by or under the direction of a physician. It may be encountered primarily in health-care settings rather than as a medication that patients routinely keep at home.

What patients should do

Patients who may have received the recalled injection should contact their doctor or health-care provider for individualized guidance, especially if they have concerns or experienced a possible problem after treatment. Patients should not independently stop, restart or change other prescribed treatment without medical advice.

The immediate question for facilities is whether they have lot 25202. Providers and patients should continue to monitor FDA and American Regent updates for additional instructions. This recall concerns one identified lot of an injectable prescription drug, not a medical device or all papaverine products.

Sources

• FDA recall notice
• American Regent recall announcement
• DailyMed Papaverine Hydrochloride Injection label