CLASS II Drug recall · Reported 22 Jun 2022 · FDA Enforcement Report
Zileuton Extended-Release Tablets, 600 mg recalled
Lupin Pharmaceuticals is recalling Zileuton Extended-Release Tablets, 600 mg, distributed nationwide in the US. The recall was initiated on 10 Jun 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1150-2022
- FDA event ID
- 90415
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2022
- FDA classified
- 15 Jun 2022
- Reported
- 22 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 10 Jun 2022 | Recall initiated by company | |
| 15 Jun 2022 | Classified by FDA | +5 days |
| 22 Jun 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Which lots are affected?
Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
Where was it sold?
Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Zileuton recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zileuton Extended-Release Tablets, 600 mg recalled by Chiesi USA | Chiesi USA | Potency & Assay | Nationwide |