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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

Oxybutynin Chloride Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: November 9, 2023
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Summary

Zydus Pharmaceuticals (USA) Inc. is recalling various strengths of Oxybutynin Chloride Extended-Release Tablets (oxybutynin), a medication used to treat overactive bladder. The recall was initiated because the tablets failed dissolution testing during long-term stability checks. This defect means the medication might not release into the body at the correct rate, which could make the treatment less effective. No injuries or adverse health events have been reported at this time.

Risk

If the medication fails to dissolve as intended, the patient may not receive the proper dose of medicine over time, potentially leading to a return of urinary symptoms like urgency or frequency. No incidents or injuries have been reported to the company as of the recall date.

What You Should Do

  1. This recall affects Zydus Pharmaceuticals Oxybutynin Chloride Extended-Release Tablets USP in 5 mg, 10 mg, and 15 mg strengths, sold in 100-count bottles.
  2. Check the NDC number and lot code on your prescription bottle to see if your medication is affected. See the Affected Products section below for the full list of affected codes.
  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. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred if you choose to dispose of the product rather than return it.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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 Tablet USP (5 mg)
Variants: 5 mg, 100 count bottles, Rx Only
Lot Numbers:
M212749 (Exp 11/2024)
M214477 (Exp 11/2024)
M214478 (Exp 11/2024)
M214479 (Exp 11/2024)
M214480 (Exp 11/2024)
NDC:
68382-255-01

Manufactured by Cadila Healthcare Ltd, Baddi, India.

Product: Oxybutynin Chloride Extended-Release Tablet USP (10 mg)
Variants: 10 mg, 100 count bottles, Rx Only
Lot Numbers:
M213318 (Exp 11/2024)
M213314 (Exp 11/2024)
M213315 (Exp 11/2024)
M214436 (Exp 11/2024)
M214437 (Exp 11/2024)
M214438 (Exp 11/2024)
M300653 (Exp 12/2024)
M300654 (Exp 12/2024)
NDC:
68382-256-01

Manufactured by Cadila Healthcare Ltd, Baddi, India.

Product: Oxybutynin Chloride Extended-Release Tablet USP (15 mg)
Variants: 15 mg, 100 count bottles, Rx Only
Lot Numbers:
M211541 (Exp 10/2024)
M211542 (Exp 10/2024)
M212746 (Exp 10/2024)
M300660 (Exp 12/2024)
NDC:
68382-257-01

Manufactured by Cadila Healthcare Ltd, Baddi, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93260
Status: Resolved
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Sold By: Pharmacies
Manufactured In: India, United States
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.