ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL)
Recalled by American Regent, Inc.
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
American Regent, Inc. has recalled ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on August 26, 2026 and was initiated on July 24, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), with approximately 316,450 vials affected. The company behind the recall is American Regent, Inc., based in Shirley, NY. The FDA describes the product as: “ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.”
Why was ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL) recalled?
According to the FDA, the stated reason for the recall is: “Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde.” In plain terms, this recall relates to foreign material.
A foreign material recall means that pieces of something which should not be in food — such as metal, plastic, or glass — may be present. These can pose a choking hazard or cause injury. Recalls like these are issued to remove the affected product before anyone is hurt.
What should you do?
If you think you may have bought ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), compare it against the product description and identifying codes (Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact American Regent, Inc. or your local health authority.
About this recall
This recall was distributed in NY. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters to anyone who bought ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL). Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: Nationwide within the U.S.
What foreign material actually means
A foreign material recall means that pieces of something which should not be in food — such as metal, plastic, or glass — may be present. These can pose a choking hazard or cause injury. Recalls like these are issued to remove the affected product before anyone is hurt.
In this case, the concern applies specifically to ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL) from American Regent, Inc. — not to the wider category of products. Similar items from other brands aren't part of this recall.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- August 26, 2026
- Recall started
- July 24, 2026
- Distributed in
- NY
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL) recalled?+
According to the FDA: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair,…
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL)?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0796-2026. Information last synced from the FDA on September 7, 2026.