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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

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

Agency Publication Date: March 12, 2019
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Summary

Lannett Company Inc. is recalling 14,448 bottles of Oxybutynin Chloride Extended-Release Tablets (10 mg), a prescription medication used to treat overactive bladder. This recall was initiated because the tablets failed dissolution specifications, meaning the drug may not release properly into the body. This could result in the medication being less effective at managing symptoms or potentially releasing too much medicine at once. These 100-count bottles were distributed nationwide, including to Puerto Rico.

Risk

The failure to meet dissolution standards means the medication may not dissolve at the correct rate, which can lead to inconsistent blood levels of the drug and a potential failure to control bladder symptoms.

What You Should Do

  1. Check your prescription bottle for Oxybutynin Chloride Extended-Release Tablets USP, 10 mg, in 100-count bottles (NDC 62175-271-37).
  2. Specifically look for lot number 18226783A with an expiration date of 07/2021, or lot number 18232540A with an expiration date of 08/2021.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and determine if you have an affected bottle.
  4. Return any unused medication from the affected lots to your pharmacy for a refund and to obtain a proper replacement.
  5. Contact Lannett Company Inc. directly if you have additional questions regarding this recall.
  6. For further consumer safety questions, contact the FDA Consumer Complaint line 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

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 Tablet bottle)
Model:
NDC: 62175-271-37
Recall #: D-0996-2019
Lot Numbers:
18226783A (exp 07/2021)
18232540A (exp 08/2021)
Date Ranges: July 2021, August 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82144
Status: Resolved
Manufacturer: Lannett Company Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 14,448 bottles
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.