Papaverine Hydrochloride Injection, USP 60 mg/2 mL
Recalled by American Regent, Inc.
Classification pending
The agency has not yet assigned a severity class to this recall. Classification usually follows the initial announcement by several weeks — check the official notice for the latest status.
American Regent, Inc. has recalled Papaverine Hydrochloride Injection, USP 60 mg/2 mL, according to the U.S. Food and Drug Administration (FDA). The recall was announced on July 27, 2026. The FDA has not yet assigned it a severity classification — that usually follows the initial announcement by several weeks.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Papaverine Hydrochloride Injection, USP 60 mg/2 mL. The company behind the recall is American Regent, Inc.. The FDA describes the product as: “Papaverine Hydrochloride Injection, USP 60 mg/2 mL”
Why was Papaverine Hydrochloride Injection, USP 60 mg/2 mL recalled?
According to the FDA, the stated reason for the recall is: “Products were found to contain particulate matter. Injectable medicines must be free of visible particles, because particles introduced directly into the bloodstream can cause serious complications.” In plain terms, this recall relates to a sterility or contamination concern.
Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.
What should you do?
If you think you may have bought Papaverine Hydrochloride Injection, USP 60 mg/2 mL, compare it against the product description and identifying codes (This is a prescription injectable used in clinical settings. Healthcare providers should check lot numbers against the official notice. Patients should speak w…) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact American Regent, Inc. or your local health authority.
About this recall
This recall was distributed in United States. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters to anyone who bought Papaverine Hydrochloride Injection, USP 60 mg/2 mL. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: United States.
What sterility or contamination concern actually means
Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.
In this case, the concern applies specifically to Papaverine Hydrochloride Injection, USP 60 mg/2 mL from American Regent, Inc. — not to the wider category of products. Similar items from other brands aren't part of this recall.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: This is a prescription injectable used in clinical settings. Healthcare providers should check lot numbers against the official notice. Patients should speak with their provider rather than stopping treatment on their own.
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- July 27, 2026
- Distributed in
- United States
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Papaverine Hydrochloride Injection, USP 60 mg/2 mL recalled?+
According to the FDA: Products were found to contain particulate matter.
How serious is this recall?+
Classification pending. The agency has not yet assigned a severity class to this recall. Classification usually follows the initial announcement by several weeks — check the official notice for the latest status.
What should I do if I have Papaverine Hydrochloride Injection, USP 60 mg/2 mL?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: FDA-PR-PAPAVERINE-2026. Information last synced from the FDA on July 31, 2026.