FDA Drug recall D-1341-2019
ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 1012…
- FDA Drug
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 1012… by Chiesi Usa, citing failed Dissolution Specifications: Out of specification result for dissolution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1341-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-31 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Chiesi Usa |
| Distribution | US |
Product
ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
Reason
Failed Dissolution Specifications: Out of specification result for dissolution.
Identifiers
| code_info | Lots: 3171855, Exp. 12/19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1341-2019%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.