American Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
American Regent, Inc. is recalling Papaverine Hydrochloride Injection due to the presence of glass and/or paraformaldehyde particulate matter.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
American Regent, Inc. is recalling 86,100 vials of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL (30 mg/mL). The product is packaged in 2 mL single-dose vials (NDC 0517-4002-01) and 25x2 mL single-dose vials (NDC 0517-4002-25). The affected lot number is 25202, with an expiration date of 11/30/2026. The product was distributed nationwide within the U.S.
The recall was initiated because the product was found to be contaminated with particulate matter identified as glass and/or paraformaldehyde. This is a prescription-only medication intended for intravenous use.
Healthcare providers and patients should discontinue use of the affected lot and contact American Regent, Inc. for further instructions or returns.
The recalled product
- Product
- PAPAVERINE HYDROCHLORIDE (PAPAVERINE HYDROCHLORIDE)
- Brand
- PAPAVERINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injection
- Affected units
- 86,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 25202
- Exp. Date: 11/30/2026.
UPCs (1)
- 0305174002257
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · PAPAVERINE HYDROCHLORIDE
- HighDrug recall: Papaverine hydrochloride injection due to sterility concerns
FDA (Drugs) · 2022-04-13
Same manufacturer · American Regent, Inc.
See all →- SevereFDA Recalls Nicardipine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Multrys Trace Elements Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Atropine Sulfate Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
Same hazard · particulate matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- SevereAmerican Regent Recalls Tralement Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26