Chiesi USA recalls 600mg Zileuton Extended-Release Tablets due to failed dissolution testing. This may affect medication effectiveness. Contact your doctor for guidance.
“Chiesi Zileuton 600mg Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38733-chiesi-zileuton-600mg-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-1342-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1342-2019%22&limit=1).
The FDA announced on May 31, 2019, that Chiesi USA, Inc. voluntarily recalled Zileuton Extended-Release Tablets due to failed dissolution specifications. The recall covers 2,598 bottles distributed nationwide.
The recall was initiated because the Zileuton Extended-Release Tablets produced out-of-specification results for dissolution. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Chiesi USA, Inc. has had three other recalls since March 17, 2026, including the Aug. 19, 2026, Revcovi Injection recall for failed stability tests and the July 6, 2026, CLEVIPREX injectable vials recall for sterility risks. Other recent recalls of similar products include the Jan. 29, 2026, Teva Metoprolol Succinate Tablets recall and the Sept. 3, 2026, Inventia Chlorthalidone recall, both citing failed dissolution specifications.
How to tell if you have this one
Check for 600mg Zileuton Extended-Release Tablets in 120-count bottles with NDC 66993-485-32. The product was distributed by Prasco Laboratories in Mason, OH.
Brand
Chiesi
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1342-2019 (May 31, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1342-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
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