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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

AVKARE Inc.: Oxybutynin Chloride Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: March 11, 2019
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Summary

AVKARE Inc. is recalling 6,326 bottles of Oxybutynin Chloride Extended-Release Tablets USP (10 mg), used to treat overactive bladder. The recall was initiated because the tablets failed to meet dissolution specifications, which means the medication may not release properly into the body. This could result in the drug being less effective or not working as intended for patients.

Risk

If the medication fails to dissolve correctly, the patient may not receive the intended therapeutic dose, potentially leading to a return or worsening of overactive bladder symptoms. There have been no reported injuries or adverse events related to this recall at this time.

What You Should Do

  1. Identify your medication by checking the bottle for Oxybutynin Chloride Extended-Release Tablets USP, 10 mg, and look for NDC numbers 42291-634-01 (100-count bottle) or 42291-634-50 (500-count bottle).
  2. Check the lot number and expiration date on your bottle: look for Lot 22738 with Expiration 07/2020 (100-count) or Lot 22739 with Expiration 07/2020 (500-count).
  3. If your medication matches these lot numbers, contact your healthcare provider or pharmacist for guidance on obtaining a replacement and continuing your treatment.
  4. Return any unused product to the pharmacy where it was purchased for a full refund.
  5. Contact the manufacturer, AVKARE Inc., at their facility in Pulaski, Tennessee, for further instructions regarding this recall.
  6. For additional questions or to report an issue, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Oxybutynin Chloride Extended-Release Tablets USP 10 mg (100 tablets)
Model:
NDC 42291-634-01
Lot Numbers:
22738 (Exp. 07/2020)
Date Ranges: Exp. 07/2020
Product: Oxybutynin Chloride Extended-Release Tablets USP 10 mg (500 tablets)
Model:
NDC 42291-634-50
Lot Numbers:
22739 (Exp. 07/2020)
Date Ranges: Exp. 07/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82296
Status: Resolved
Manufacturer: AVKARE Inc.
Manufactured In: United States
Units Affected: a) 2947 and b) 3379
Distributed To: Nationwide

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.