Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0517-7604-25 recalled?

Acetylcysteine · 25 VIAL, GLASS in 1 TRAY (0517-7604-25) / 4 mL in 1 VIAL, GLASS

Yes — this exact package was recalled

1 FDA recall names the code 0517-7604-25 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

1 of these recalls is still ongoing.

Active ingredient
acetylcysteine
Strength
ACETYLCYSTEINE 200 mg/mL
Form
Inhalant · Respiratory (inhalation)
Labeler
American Regent, Inc.
Type
Human Prescription Drug
Product code
0517-7604

Recalls naming this package

Class II · Moderate risk

Acetylcysteine Solution

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

Ongoing Particulate / foreign matter American Regent, Inc. NDC 0517-7604-01 D-0797-2026

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler