Zileuton Extended-Release Tablets — Class II drug recall D-1150-2022
Terminated recall by Lupin Pharmaceuticals Inc., reported 2022-06-22, distributed nationwide. Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during lo
| Recall number | D-1150-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2022-06-10 |
| Classified | 2022-06-15 |
| Reported by FDA | 2022-06-22 |
| Terminated | 2023-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 3,216 bottles |
| Reason classes | specification failure |
| NDC | 68180-0169-16 |
| Lot numbers | 06/22, 09/22, 10/22, M100070, M100239, M100312, M100366 |
Product
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Reason for recall
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
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-1150-2022. 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.