Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Papaverine HCl Injection (Papaverine Hydrochloride)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Affected NDCs
0517-4002-01
0517-4002-25
Compare with the code on your package — it is the most precise check available.
Drug: Papaverine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Papaverine Hydrochloride NDC 00517-4002 |
30 mg/mL | Injection, Solution Intravenous |
American Regent, Inc. | Rx |
- Recalling firm
- American Regent, Inc.
- NDC code
- 0517-4002-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jul 24, 2026 · FDA notice with lot numbers
- FDA recall number
- D-0800-2026 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Papaverine recalls
See all
Class II · Moderate risk
BiMix STD 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 002
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix Injection
Lack of Assurance of Sterility
Other recalls by American Regent, Inc.
All 2026 recalls
Class I · High risk
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Class II · Moderate risk
niCARdipine Hydrochloride Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class II · Moderate risk
Tralement (trace elements injection 4*, USP)
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class II · Moderate risk
Multrys (Trace Elements Injection 4, USP)
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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