Zileuton Extended-Release Tablets — Class II drug recall D-1342-2019
Terminated recall by Chiesi USA, Inc., reported 2019-06-19, distributed nationwide. Failed Dissolution Specifications: Out of specification result for dissolution.
| Recall number | D-1342-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Chiesi USA, Inc., Cary, NC, United States |
| Recall initiated | 2019-05-31 |
| Classified | 2019-06-13 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2021-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 2,598 bottles |
| Reason classes | specification failure |
| NDC | 66993-0485-32 |
| Lot numbers | 12/19, 3171856 |
Product
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Reason for recall
Failed Dissolution Specifications: Out of specification result for dissolution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1342-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.