Alembic Pharmaceuticals Recalls Fesoterodine Fumarate Extended-Release Tablets Due to Impurity Levels
Key Clinical Summary
- Alembic Pharmaceuticals issued a Class III voluntary recall of Fesoterodine Fumarate extended-release tablets, 4 mg (lot #2405006633) due to Diester Impurity levels exceeding specifications.
- Approximately 4884 bottles distributed nationwide are affected; no press release was issued, and the recall remains ongoing.
- Indication: Used for overactive bladder management. Pharmacists should check inventory and follow recall protocols for the identified lot.
Alembic Pharmaceuticals Limited has initiated a voluntary Class III recall of Fesoterodine Fumarate extended-release tablets, 4 mg (NDC 62332-175-30) packaged in 30-count bottles. The affected lot is #2405006633 with an expiration date of March 31, 2026, and a total of 4884 bottles were distributed nationwide in the US. The product, manufactured at Alembic’s facility in Gujarat, India, and distributed by Alembic Pharmaceuticals, Inc in Bedminster, New Jersey, is a prescription-only medication.
According to the US Food and Drug Administration (FDA) Enforcement Report, the recall was initiated on October 10, 2025, after the product was found to have failed impurities and degradation specifications, with levels of a “Diester Impurity” exceeding acceptable limits. Although classified as Class III, indicating that exposure to the violative product is not likely to cause adverse health consequences. The recall remains ongoing as of November 2025. Alembic notified its consignees through multiple communication methods, including email, fax, letter, and telephone, though no public press release was issued.
Fesoterodine Fumarate is an antimuscarinic agent indicated for the treatment of overactive bladder with symptoms such as urinary urgency, frequency, and urge incontinence. Pharmacists and health care professionals should verify stock for the affected lot and follow recall instructions to ensure that compromised product is removed from distribution channels.
