FDA Drug recall D-0796-2026
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…
- FDA Drug
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of 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… by American Regent, citing presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0796-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-24 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Regent |
| Distribution | US |
Product
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.
Reason
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Identifiers
| ndc | 0517-7504-25 |
|---|---|
| ndc | 0517-7604-25 |
| ndc | 0517-7510-03 |
| ndc | 0517-7610-03 |
| ndc | 0517-7630-03 |
| ndc | 0517-7504-01 |
| code_info | Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0796-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.