Recall Update: American Regent Papaverine Hydrochloride Injection (60 mg/2 mL) — Stop Use if You Have the Recalled Lot
If you (or a caregiver) have prescription papaverine hydrochloride injection, USP (60 mg/2 mL) single-dose vials from American Regent, pause before using it. The FDA reports a voluntary nationwide recall of one lot because the product may contain particulate matter (described as glass and/or paraformaldehyde).
At this point, FDA says it has not received adverse event reports as of the recall notice. Still, the safest next step is to check your vial identifiers and follow the recall instructions.
What product is being recalled?
The FDA notice covers American Regent, Inc. voluntary recall of:
- Product: Papaverine Hydrochloride Injection, USP
- Strength/size: 60 mg/2 mL single-dose vials
Why is it being recalled?
According to the FDA, the recalled lot may contain particulate matter that is described as glass and/or paraformaldehyde.
What to check on your vial (identifiers that must match)
Before using any remaining vials, look for the recall identifiers on your packaging and vial labels. Compare them to the details in the FDA notice for the recalled lot:
- Lot number
- NDC (National Drug Code)
- Expiration date
If your lot/NDC/expiration match the recalled identifiers, do not use the vials. Keep them available so you can follow the return or disposal instructions in the recall notice.
What to do right now
- Stop using the recalled vials if your identifiers match.
- Keep the product so you can carry out the recall instructions (return/disposal steps are provided in the FDA notice/company guidance).
- Contact your physician or healthcare provider before making any treatment changes. Don’t substitute or adjust dosing on your own based on the recall.
Return or disposal instructions
The recall notice provides specific instructions for how to return or dispose of the affected vials. Follow the steps in the FDA notice for the product you have—don’t rely on general “throw it away” guidance.
Has FDA received reports of problems?
FDA notes that, as of the time of the notice, it had not received adverse event reports related to this recall. That doesn’t change the basic action step: check identifiers and stop use if they match.
Where to find the official details
For the exact recalled lot identifiers (including the lot number, NDC, and expiration date), refer to the FDA’s recall notice for the American Regent papaverine injection update.
Calm, practical next steps
- Look for the lot number and matching NDC on any papaverine vials in your home or facility supply.
- If it matches the recalled lot, stop use and follow the return/disposal instructions.
- Talk with your healthcare provider about what to do next.
