Papaverine Injection Recall: Steps for Patients and Clinics (Lot 25202)

If you (or your clinic) may have received papaverine hydrochloride injection from American Regent, do a quick check of the lot number. FDA posted a voluntary nationwide recall of one lot because the product was found to contain visible particulate matter.

The safest next step is to confirm whether your vial matches the affected lot and follow the recall instructions. If you (or the patient who received it) develops stroke-like symptoms or other serious neurologic signs, seek emergency care right away.

What the FDA recall covers

FDA states that American Regent is conducting a voluntary nationwide recall of Papaverine Hydrochloride Injection, USP (60 mg/2 mL) due to visible particulate matter (described as glass and/or paraformaldehyde). The recall is for a single lot:

Lot: 25202
NDC: 0517-4002-25
Expiration date: 11/30/2026

FDA also states that injecting an injectable product containing particulate matter may lead to local irritation or swelling, and that the particulate matter could potentially travel and block blood vessels in the heart, lungs, or brain, which can cause stroke and may lead to death.

First priority for patients/caregivers: check your product

Check the label right away. Look for the lot number and NDC on the vial/box.
If you have the affected lot (25202): stop using it / do not administer additional doses. Contact your clinician for direction on next steps.
Keep the packaging. Save the vial/box (including lot details) so your healthcare team can identify it if needed.

If you already received a dose: what to do now

If you have symptoms that could be serious: seek emergency care or call 911.
If you feel well: it’s still a good idea to contact your clinician or pharmacist and let them know you may have received lot 25202, so they can document it and advise on appropriate monitoring.

First priority for clinics/facilities: locate and manage the lot

Locate and verify inventory. Match NDC and lot #25202 to any papaverine vials in stock.
Quarantine/hold the recalled lot. FDA directs healthcare facilities to stop using the affected product and follow the recall instructions for what to do next (return/discard as directed).
Document lot details. Record what you received/used, including lot numbers and relevant distribution/administration information.
Coordinate with your distributor/manufacturer. Follow the recall notice for how replacement/return actions should be handled.
Inform relevant staff. Share lot-specific details so the correct vials are identified during the recall period.

Serious warning: stroke symptoms—call 911

FDA’s concern is based on how particulate matter could potentially block blood vessels (including in the brain). That doesn’t mean a stroke will occur—but it does mean you should be alert to stroke-like symptoms.

The CDC advises calling 9-1-1 right away for sudden signs of stroke, including:

Face: one side droops (ask them to smile)
Arms: one arm drifts downward (ask them to raise both arms)
Speech: slurred or strange speech (ask them to repeat a simple phrase)
Time: note when symptoms first started

Other emergency symptoms listed by CDC include sudden trouble walking or balance, sudden trouble seeing, sudden numbness or weakness (often on one side), sudden confusion or trouble speaking/trouble understanding speech, and sudden severe headache with no known cause.

What to report to FDA (MedWatch)

If you think a health problem could be related to the recalled product—or you have information about product quality—FDA MedWatch is the reporting pathway.

Healthcare professionals can submit a report using FDA’s Form 3500.
Consumers/patients can submit a report using FDA’s Form 3500B.

FDA’s MedWatch page explains that reporting can be done online or by downloading and submitting the appropriate form(s).

What remains uncertain

Harm is not guaranteed. This recall is a precaution based on particulate contamination—not proof that every dose caused injury.
Symptoms can matter immediately. If stroke-like signs appear after an injection, emergency evaluation is still the priority.
FDA states no recall-related adverse events were reported at posting. FDA’s recall notice states American Regent had not received reports of adverse events related to this recall at the time it was posted.

Key questions to ask your clinician or pharmacist

Did I/our facility administer papaverine injection from lot 25202?
If so, what symptoms should this patient be monitored for, and what follow-up is recommended?
How should we handle the recalled vial(s)—and what documentation is needed for return/discard or replacement?
For relevant care contexts, what is the facility’s plan for rapid escalation if severe complications develop?

Clinician-adjacent context: If papaverine is used in settings that may involve emergency presentations (such as priapism-related workflows), facilities should align on escalation steps using applicable professional guidance.

Key sources

Editorial note: Weence articles are researched from cited public-health, medical, regulatory, journal, and reputable news sources and may be drafted with AI assistance. They are checked for source support, clarity, and safety guardrails before publication.

This article is for general informational purposes only and is not medical advice. Research findings can be early or incomplete, and health guidance can change. Always talk with a qualified healthcare professional about personal symptoms, diagnosis, medications, vaccines, screenings, or treatment decisions. If you think you may have a medical emergency, call emergency services right away.