FDA Drug recall D-1150-2022
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by…
- FDA Drug
- Class II
- terminated
- Published 2022-06-22
On 2022-06-22 the FDA classified a Class II recall of Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by… by Lupin Pharmaceuticals, citing failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1150-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-10 |
| Published | 2022-06-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Identifiers
| code_info | Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Lupin Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1150-2022%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.