Class I U.S. Food and Drug Administration

American Regent, Inc. Papaverine HCl Injection, USP, 60 mg/2 mL recall: Presence of Particulate Matter: Product contaminated with particulate matter

Recall published 2 months ago

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0800-2026
Published
August 26, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
American Regent, Inc.
Product type
Prescription & OTC drugs
Units affected
86,100 vials
Distribution
Nationwide
Made in
United States
Lot / code info
Lot #: 25202, Exp. Date: 11/30/2026.

Products covered by this recall

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.

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25202

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 11
  • 30
  • 2026. — 86
  • 100 vials

NDC number

On the carton and again on the bottle or blister label.

  • 0517-4002-01
  • 0517-4002-25

Package size

Match the net weight or the piece count on the front of the pack.

  • 60 mg
  • 2 mL
  • 30 mg

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

American Regent, Inc. — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: American Regent, Inc. — 5 Ramsay Rd, Shirley, NY, 11967-4701

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was American Regent, Inc. prescription & otc drugs recalled?

Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 25202; best-by date 11 or 30. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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