---
title: "American Regent, Inc.: Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL — FDA announcement Jul 27, 2026 | Is It on Recall"
description: "Products were found to contain particulate matter"
url: https://isitonrecall.com/recall/fdapress-ca189560b1a5bd76-american-regent-inc-papaverine-hydrochloride-injection-usp-60-mg-2-ml/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# American Regent, Inc.: Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL — FDA announcement Jul 27, 2026

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jul 27, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL
- **Reason**: Products were found to contain particulate matter
- **Classification**: Not supplied
- **Recalling firm**: American Regent, Inc.
- **Quantity**: Not supplied
- **Agency-reported status**: Company recall announcement
- **Source record identifier**: ca189560b1a5bd76

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-one-lot-papaverine-hydrochloride-injection)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consumer level. The product is being recalled due to the presence of particulate matter identified as glass and/or paraformaldehyde.; Papaverine Hydrochloride Injection, USP Lot # 25202 was distributed nationwide in the United States beginning September 30, 2025. NDC, lot, expiration date and distribution dates can be found on the table below.; Product Description: Papaverine Hydrochloride Injection, USP 60 mg/2 mL Single dose vial NDC: 0517-4002-25 Lot#: 25202 Expiration Date: 11/30/2026 Distribution Dates: 9/30/2025; Contact Center \| Contact Information \| Area of Support; American Regent, Inc. Customer Service \| Phone: 800-645-1706 (8:00AM-6:00PM EST, Monday – Thursday, 8:00AM-4:00PM EST, Friday) \| For detailed return/replacement/credit information; American Regent, Inc. Pharmacovigilance \| Phone: 800-734-9236 Email: pv@americanregent.com \| To report adverse events; American Regent, Inc. Product Quality Complaints \| Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: pqc@americanregent.com \| For product quality complaints; American Regent, Inc. Medical Information \| Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: ma@americanregent.com \| For medical questions |

Match all identifying details in the current notice. A brand name alone is not enough.

## Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

**FDA company announcement, table 1**

| Contact Center | Contact Information | Area of Support |
| --- | --- | --- |
| American Regent, Inc. Customer Service | Phone: 800-645-1706 (8:00AM-6:00PM EST, Monday – Thursday, 8:00AM-4:00PM EST, Friday) | For detailed return/replacement/credit information |
| American Regent, Inc. Pharmacovigilance | Phone: 800-734-9236 Email: pv@americanregent.com | To report adverse events |
| American Regent, Inc. Product Quality Complaints | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: pqc@americanregent.com | For product quality complaints |
| American Regent, Inc. Medical Information | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: ma@americanregent.com | For medical questions |

Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-one-lot-papaverine-hydrochloride-injection).

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Jul 27, 2026
- **Company announcement date**: Jul 24, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Consumers and healthcare professionals with questions regarding this recall can contact American Regent Inc. using the below information. This product is an intravenous injection and is to be used by or under the direction of a physician. Patients that use this product which is being recalled should stop using them and contact their doctor or health care provider. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-regent-inc-issues-voluntary-nationwide-recall-one-lot-papaverine-hydrochloride-injection)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [American Regent, Inc. records](https://isitonrecall.com/brand/american-regent-inc/)