Zydus Pharmaceuticals recalls 5mg Oxybutynin Chloride Extended-Release Tablets due to failed dissolution tests at 6 months. Affected products have NDC # 68382-255-01 and expire 11/2024.
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Zydus Pharmaceuticals is recalling 5mg Oxybutynin Chloride Extended-Release Tablets that failed dissolution tests at the 6-month mark. This could mean the medication doesn't work properly over time, but the recall does not mention any injuries or immediate safety risks.
The medication failed dissolution tests at the 6-month time point, meaning it may not release the drug properly over time. This could lead to inconsistent dosing, but the recall does not indicate immediate safety risks like injury or death.
People with prescriptions for Oxybutynin Chloride Extended-Release Tablets from Zydus Pharmaceuticals (USA) Inc. Those who have the specific NDC # 68382-255-01 bottles are most affected.
Check for NDC # 68382-255-01 on the bottle label. The product is a 5mg Oxybutynin Chloride Extended-Release Tablet USP, 100-count bottle, Rx Only, manufactured by Cadila Healthcare in India and distributed by Zydus Pharmaceuticals (USA) Inc.
Look for NDC # 68382-255-01 on the bottle label to confirm if it's affected.
The recall states the product failed dissolution tests at 6 months, but does not mention safety risks. It may not work properly over time, but the recall does not indicate immediate injury risks.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected product.
Check for NDC # 68382-255-01 on the bottle label. The product is a 5mg Oxybutynin Chloride Extended-Release Tablet USP, 100-count bottle, Rx Only, manufactured by Cadila Healthcare in India and distributed by Zydus Pharmaceuticals (USA) Inc.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0096-2024 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0096-2024 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.
