Zydus Oxybutynin Tablets Recall: Failed Dissolution Risk
Zydus Pharmaceuticals recalls 100 and 500-tablet Oxybutynin Chloride Extended-Release tablets due to failed dissolution specifications. This may affect medication effectiveness.
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Failed Dissolution Specifications
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What happened, in plain English
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. Read more at govinfonow.com/recall/33103-zydus-oxybutynin-tablets-recall-failed-dissolution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33103-zydus-oxybutynin-tablets-recall-failed-dissolution-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0038-2024
Cite this page
“Zydus Oxybutynin Tablets Recall: Failed Dissolution Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33103-zydus-oxybutynin-tablets-recall-failed-dissolution-risk. Based on FDA recall #D-0038-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0038-2024%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Zydus Pharmaceuticals- Category
Drug
What to do — step by step
Check Medication Details
Look for the NDC codes 68382-256-01 or 68382-256-05 on the bottle label to confirm if your tablets are recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0038-2024 (September 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0038-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.