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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

Major Pharmaceuticals Tolterodine Tartrate Capsules Recalled for Dissolution

Agency Publication Date: March 28, 2025
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Summary

Major Pharmaceuticals has recalled 224 cartons of Tolterodine Tartrate Extended-Release Capsules (2 mg), a prescription medication used to treat overactive bladder. The recall was initiated because routine stability testing showed the capsules did not meet the required specifications for how the drug dissolves in the body. This issue could potentially affect how the medication is released and absorbed in your system.

Risk

If the medication does not dissolve at the specified rate, it may not work effectively to treat symptoms. To date, there have been no reported injuries or adverse events related to this recall.

What You Should Do

  1. This recall affects Major Pharmaceuticals Tolterodine Tartrate Extended-Release Capsules (2 mg) sold in 30-count unit dose cartons (NDC 0904-6592-04) with lot number T05393 and an expiration date of 09/30/2025.
  2. 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.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Tolterodine Tartrate Extended-Release Capsules (2 mg, 30 Capsules)
Variants: 2 mg, Extended-Release, 30 Capsules (3 x 10) Unit Dose carton
Lot Numbers:
T05393 (Exp. 09/30/2025)
NDC:
0904-6592-04

Recall #: D-0304-2025; Distributed by Major Pharmaceuticals

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96416
Status: Resolved
Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Sold By: Major Pharmaceuticals; Rugby Laboratories
Manufactured In: United States
Units Affected: 224 cartons
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.