Zydus Pharmaceuticals recalls 100 and 500-tablet Oxybutynin Chloride Extended-Release tablets due to failed dissolution specifications. This may affect medication effectiveness.
Failed Dissolution Specifications
Zydus Pharmaceuticals is recalling Oxybutynin Chloride Extended-Release Tablets (100 and 500 tablets) because they failed dissolution tests. This could mean the medication doesn't work as intended, which is important for people using it for overactive bladder.
The tablets failed dissolution specifications, meaning they may not release the medication properly in the body. This could lead to the medication not working as intended, but it does not cause immediate harm or injury.
People with prescriptions for Oxybutynin Chloride Extended-Release Tablets (10 mg) who received these specific bottle sizes (100 or 500 tablets) from Zydus Pharmaceuticals (USA) Inc. Those most at risk are individuals relying on this medication for overactive bladder symptoms.
Check for bottles labeled 'Oxybutynin Chloride Extended-Release Tablets USP 10 mg' with either 100 tablets (NDC 68382-256-01) or 500 tablets (NDC 68382-256-05). These were manufactured by Cadila Healthcare Ltd. in India and distributed by Zydus Pharmaceuticals (USA) Inc.
Look for the NDC codes 68382-256-01 or 68382-256-05 on the bottle label to confirm if your tablets are recalled.
The recall is due to failed dissolution specifications, which may affect medication effectiveness but does not cause immediate harm. Consult your doctor if you have concerns.
Check for bottles labeled 'Oxybutynin Chloride Extended-Release Tablets USP 10 mg' with NDC codes 68382-256-01 (100 tablets) or 68382-256-05 (500 tablets).
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance on whether to continue using the medication.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0038-2024 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0038-2024 from Zydus 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.
