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Lower risk Drug recall · FDA · Published October 19, 2023

Zydus Oxybutynin Tablets Recall: Failed Dissolution Test Results

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0096-2024DrugZydus Pharmaceuticals ›
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Contact the company

Recalling firmZydus Pharmaceuticals (USA) Inc73 Route 31 N · Pennington, NJ 08534-3601
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/33048-zydus-oxybutynin-tablets-recall-failed-dissolution-test-results.

Source Summary by GovInfoNow · govinfonow.com/recall/33048-zydus-oxybutynin-tablets-recall-failed-dissolution-test-results · Updated August 17, 2026 · FDA enforcement record: FDA #D-0096-2024

Cite this page

“Zydus Oxybutynin Tablets Recall: Failed Dissolution Test Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33048-zydus-oxybutynin-tablets-recall-failed-dissolution-test-results. Based on FDA recall #D-0096-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0096-2024%22&limit=1).

Zydus Pharmaceuticals (USA) Inc recalled Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles due to failed dissolution specifications, according to the FDA on 2023-10-19.

How to tell if you have it

  • Brand: Zydus Pharmaceuticals
  • Product: Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles
  • NDC # 68382-255-01
  • Lot codes: M212749 (exp. date 11/2024), M214477 (exp. date 11/2024), M214478 (exp. date 11/2024), M214479 (exp. date 11/2024), M214480 (exp. date 11/2024)
  • Manufacturer: Cadila Healthcare Ltd, Baddi, India
  • Distributor: Zydus Pharmaceuticals (USA) Inc
  • Distribution: Nationwide

The hazard

The recall addresses out-of-specification test results observed for dissolution at the 6 month long term time point.

Context

GovInfoNow's records show Zydus Pharmaceuticals (USA) Inc has 53 other recalls on record since 2012-03-14. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets Recall (2026-08-05), Zydus Erythromycin Tablets Recall (2026-04-29), and Zydus Recalls Icosapent Ethyl Capsules Due to Defects (2026-03-09). Other recent recalls of similar products include Golden State NIACIN Extended-Release Tablets Recall (2026-05-29), Ascend Minocycline Tablets Recall (2026-06-01), and Lannett Niacin Extended-release Tablets Recall (2026-05-27).

How to tell if you have this one

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.

  • Brand
    Zydus Pharmaceuticals
  • Category
    Drug
FDA recall event · 3 products

All 3 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.

  • Classification
    Class II
  • Status
    Completed
  • Distribution
    Nationwide.
  • NDC
    68382-255-06, 68382-255-14, 68382-255-16, 68382-255-01, 68382-255-05, 68382-255-30, 68382-255-77, 68382-256-14, 68382-256-01, 68382-256-16, 68382-256-05, 68382-256-30, 68382-256-77, 68382-256-06, 68382-257-14, 68382-257-01, 68382-257-16, 68382-257-05, 68382-257-30, 68382-257-77, 68382-257-06
Recall numberProduct, codes & lotsQuantity
D-0096-2024Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01; M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024—
D-0097-2024Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.; M213318, exp. date 11/2024; M213314, exp. date 11/2024; M213315, exp. date 11/2024; M214436, exp. date 11/2024; M214437, exp. date 11/2024; M214438, exp. date 11/2024; M300653, exp. date 12/2024; M300654, exp. date 12/2024—
D-0098-2024Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.; M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024—
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for NDC # 68382-255-01 on the bottle label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 27 days after the firm started it.

1. Firm started the recall: Oct 19, 202312. FDA classified it Class II: Nov 8, 202323. Published in FDA’s Enforcement Report: Nov 15, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Other Zydus Pharmaceuticals recalls

Zydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda,
August 5, 2026Zydus Pharmaceuticals (USA) Inc recalls Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad,
April 29, 2026Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd.,
March 9, 2026Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India,
December 30, 2025Zydus Pharmaceuticals (USA) Inc recalls traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India,
December 19, 2025

Latest drug recalls

Apotex Corp. recalls Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario,
Apotex · September 23, 2026

Keep exploring

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-0096-2024 (October 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0096-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA