Acetylcysteine recalls
Acetylcysteine products have been recalled 2 times, most recently on 26 Aug 2026. The recalling company is usually American Regent. The most common reason is particulate matter.
Total recalls2since 2026
Last 12 months2reported
Class I00% of total
Ongoing2latest 26 Aug 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why acetylcysteine is recalled
Companies
Product types
By year
Ongoing acetylcysteine recalls
2 active| 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 Solution, USP, 20% (200 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
All acetylcysteine recalls, newest first
2 total| 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 Solution, USP, 20% (200 mg/mL) recalledAcetylcysteine | American Regent | Particulate Matter | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.