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Class III · Lower riskActive recall

Fesoterodine Fumarate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot# 2405003360, Exp Date: Jan 31, 2026
Where it was soldUS Nationwide and PR.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAlembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA foreign manufacturer
Brand nameFESOTERODINE FUMARATE
Generic nameFESOTERODINE FUMARATE
Active ingredient(s)FESOTERODINE FUMARATE
Distributed by / forAlembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA
NDC62332-176-30
Show the full FDA record
Full product labelFesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
Recalling firmAlembic Pharmaceuticals Limited
DistributionUS Nationwide and PR.
Recall initiated2025-12-16
Report date2026-01-14
Recall completed—
Recall numberD-0248-2026
ClassificationClass III
FDA statusOngoing
Origin on filePanchmahal India

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.