⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Alembic Pharmaceuticals Limited: Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350

DrugsSource: FDA (drug) · Date: 2026-01-14

Read the official notice at FDA (drug) →

Share on XFacebookRedditEmail

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Alembic Pharmaceuticals Limited
Product
Fesoterodine 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
Reason / hazard
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Classification
Class III
Status
Ongoing
Distribution / sold at
US Nationwide and PR.
Recall initiated
2025-12-16
Code info
Lot# 2405003360, Exp Date: Jan 31, 2026
Voluntary mandated
Voluntary: Firm initiated
City
Panchmahal
Country
India
Event id
98119
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.