CLASS II ONGOING Drug recall · Reported 26 Aug 2026 · FDA Enforcement Report
Acetylcysteine Solution, USP, 20% (200 mg/mL) recalled
American Regent is recalling Acetylcysteine Solution, USP, 20% (200 mg/mL), distributed nationwide in the US. The recall was initiated on 24 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0797-2026
- FDA event ID
- 99503
- Recalling firm
- American Regent, Shirley, NY
- Brand
- Acetylcysteine
- Manufacturer
- American Regent, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jul 2026
- FDA classified
- 26 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Jul 2026 | Recall initiated by company | |
| 26 Aug 2026 | Classified by FDA | +33 days |
| 26 Aug 2026 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Product as listed by the FDA
ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Where it was distributed
Nationwide within the U.S
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Which lots are affected?
Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 99503This product is part of a recall event; the main page for the event is Cyanocobalamin injection USP, 10,000 mcg/ (1,000 mcg/mL) recalled.
More recalls from American Regent
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine Injection, USP, 30 mg/ (1mg/mL)-Multiple-Dose Vial recalledEpinephrine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Tralement (trace elements injection 4*, USP) recalled by American RegentTralement | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalledSelenious Acid | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid | American Regent | Particulate Matter | Nationwide |
Other Acetylcysteine recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetylcysteine Solution, USP, 10% (100 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetylcysteine 10% Ophthalmic Solution recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Acetylcysteine Ophthalmic Solution, 100mg/ml recalled | Promise Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Acetylcysteine Injection 10 mg/ (2 mg/mL) recalled by Pharm D Solutions | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Acetylcysteine for Injection (200 mg/mL) recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |