Lupin Pharmaceuticals recalls 600mg Zileuton Extended-Release Tablets due to failed dissolution testing. Rx-only medication with specific batch numbers and expiration dates. Consumers should contact manufacturer for details.
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Lupin Pharmaceuticals is recalling 600mg Zileuton Extended-Release Tablets that failed dissolution testing during stability studies. This means the medication may not release properly in the body, potentially affecting effectiveness. The recall applies to specific batch numbers and expiration dates.
The tablets failed dissolution testing, meaning they may not release the medication properly in the body. This could lead to reduced effectiveness but does not indicate immediate safety risks like injury or death.
Prescription medication users who purchased the specific batch numbers and expiration dates listed. Most at risk are those with a prescription for this medication.
Check for the product name 'Zileuton Extended-Release Tablets, 600 mg, 120-count bottle', Rx only. Look for batch numbers M100070, M100239, M100312, M100366 and expiration dates up to 10/22.
Identify the batch numbers and expiration dates listed in the recall notice to confirm if your product is affected.
The recall is due to failed dissolution testing, which may affect effectiveness but does not indicate immediate safety risks like injury or death.
Contact Lupin Pharmaceuticals directly for specific instructions on what to do with the affected product.
Check the batch numbers and expiration dates listed in the recall notice: M100070, M100239, M100312, M100366 with expiration dates up to 10/22.
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1150-2022 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-1150-2022 from Lupin Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
