FDA recall, , Low risk
Alembic Fesoterodine Fumarate Extended-Release Tablets
Failed impurities/degradation specifications due to levels of 'Diester Impurity' exceeding the specification limit.
Summary by Recall Canary from the FDA notice
What happened
Alembic Pharmaceuticals Limited, located in Panchmahal, India, is recalling Fesoterodine Fumarate Extended-release Tablets, 8 mg, 30 Tablets, Rx only. The recall was initiated on December 16, 2025, because the product failed impurities/degradation specifications due to levels of 'Diester Impurity' exceeding the specification limit. The product was distributed nationwide in the US and PR.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC or UPC is listed.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Fesoterodine Fumarate, Extended-release Tablets
- Strength
- 8 mg
- UPC
- 2405003360
- Recall number
- D-0248-2026
- NDC
- 62332-176-30
Recall details
- Company began the recall
- Sold in
US Nationwide and PR.
- Company
- Alembic Pharmaceuticals LimitedPanchmahal, India
- Hazard
- Drug impurity
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98119
- Recall number
- D-0248-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
