Recall archive / 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. Source coverage and dates.
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
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: [email protected] | To report adverse events; American Regent, Inc. Product Quality Complaints | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: [email protected] | For product quality complaints; American Regent, Inc. Medical Information | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: [email protected] | 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.
| 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: [email protected] | To report adverse events |
| American Regent, Inc. Product Quality Complaints | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: [email protected] | For product quality complaints |
| American Regent, Inc. Medical Information | Phone: 888-354-4855 (9:00AM-5:00PM EST, Monday – Friday) Email: [email protected] | For medical questions |
Announcement retrieved Oct 1, 2026. Official announcement.
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.