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FDA · Drugs ·

Nitroglycerin injection recall

American Regent, Inc. recalled Nitroglycerin injection on August 26, 2026 because of presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde. It was sold nationwide.

Why it was recalled

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

What's recalled

Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.

Quantity: 98,200 vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
American Regent, Inc., Shirley, NY
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide within the U.S
Status
Ongoing
Recall number
D-0791-2026
Source
U.S. Food and Drug Administration

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