Major Pharmaceuticals recalls 2mg Tolterodine Extended-Release Capsules due to failed dissolution testing in stability checks. This may affect medication effectiveness. Check your NDC 0904-6592-04 lot numbers.
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Major Pharmaceuticals is recalling 2mg Tolterodine Tartrate Extended-Release Capsules because stability testing showed they didn't dissolve properly. This could mean the medication isn't working as intended, so affected users should stop using the product.
The capsules failed dissolution testing during routine stability checks, meaning they don't release the medication properly in the body. This could lead to the medication not working as intended, but it doesn't cause immediate harm.
People with prescriptions for this medication who received the recalled lot numbers (T05393) are affected. Those with chronic urinary symptoms may be most at risk if the medication isn't effective.
Check for the NDC code 0904-6592-04 on the carton. The lot number T05393 and expiration date 09/30/2025 are specific to this recall.
Look for the NDC code 0904-6592-04 and lot number T05393 on the carton.
No immediate danger is reported. The recall is due to failed dissolution testing, which may affect medication effectiveness but doesn't cause injury.
Check for NDC 0904-6592-04 and lot number T05393 on the carton. The expiration date is 09/30/2025.
The recall doesn't specify a remedy, so contact your doctor or pharmacist for guidance.
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0304-2025 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0304-2025 from Major Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.