CLASS II Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Zileuton Extended-Release Tablets, 600 mg recalled by Chiesi USA
Chiesi USA is recalling Zileuton Extended-Release Tablets, 600 mg, distributed nationwide in the US. The recall was initiated on 31 May 2019 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-1342-2019
- FDA event ID
- 82993
- Recalling firm
- Chiesi USA, Cary, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 May 2019
- FDA classified
- 13 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 31 May 2019 | Recall initiated by company | |
| 13 Jun 2019 | Classified by FDA | +13 days |
| 19 Jun 2019 | Published in enforcement report | +6 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 result for dissolution.
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 bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is Zileuton Extended-Release Tablets, 600 mg recalled?
Yes. Chiesi USA recalled Zileuton Extended-Release Tablets, 600 mg on 31 May 2019. The recall is Class II and its status is Terminated. Recall number D-1342-2019.
Why was it recalled?
Failed Dissolution Specifications: Out of specification result for dissolution.
Which lots are affected?
Lots: 3171856, Exp. 12/19
Where was it sold?
Nationwide in the USA.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Chiesi USA
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Revcovi (elapegademase-lvlr) Injection, 4mg/ 6 mg/mL) recalledRevcovi | Chiesi USA | Potency & Assay | MO, TN |
| Drug | CLASS II | Cleviprex (clevidipine injectable emulsion) 50 mg/ 5 mg/mL) recalledCleviprex | Chiesi USA | Sterility | Nationwide |
| Drug | CLASS II | Curosurf (poractant alfa), 240 mg recalled by Chiesi USACurosurf | Chiesi USA | Sterility | Nationwide |
| Drug | CLASS II | Zyflo CR (zileuton) extended-release tablets, 600 mg recalled | Chiesi USA | Potency & Assay | Nationwide |
Other Zileuton recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zileuton Extended-Release Tablets, 600 mg recalled | Lupin Pharmaceuticals | Potency & Assay | Nationwide |