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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Zydus Oxybutynin Chloride Tablets Recalled for Failed Dissolution

Agency Publication Date: October 4, 2023
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Summary

Zydus Pharmaceuticals (USA) Inc. is recalling 7,248 bottles of Oxybutynin Chloride Extended-Release Tablets (10 mg), used to treat overactive bladder, because the tablets failed dissolution testing. This means the medication may not dissolve at the correct rate in the body, which can impact how effectively the drug works. This recall affects both 100-count and 500-count bottles distributed nationwide, and no injuries or incidents have been reported to date.

Risk

If the medication fails to dissolve as specified, the patient may not receive the intended dose of the drug, potentially leading to a return of overactive bladder symptoms. There is also a risk that the drug could release too quickly or too slowly, impacting the safety and efficacy of the treatment.

What You Should Do

  1. This recall affects Oxybutynin Chloride Extended-Release Tablets USP 10 mg sold under the Zydus Pharmaceuticals brand in 100-tablet bottles (NDC 68382-256-01) and 500-tablet bottles (NDC 68382-256-05).
  2. Check your prescription bottle for lot numbers M300652 or M300651, both featuring an expiration date of December 2024.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Oxybutynin Chloride Extended-Release Tablets USP (10 mg)by Zydus Pharmaceuticals
Variants: 10 mg, Extended-Release, Tablet
Lot Numbers:
M300652 (Exp Dec 2024)
M300651 (Exp Dec 2024)
NDC:
68382-256-01
68382-256-05

Bottles of 100 and 500 tablets; Rx Only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93100
Status: Resolved
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 7,248 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.