[pending] FESOTERODINE FUMARATE (FESOTERODINE FUMARATE)
Pending LLM rewrite. Source: FDA_DRUG D-0248-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
The recalled product
- Product
- FESOTERODINE FUMARATE (FESOTERODINE FUMARATE)
- Brand
- FESOTERODINE FUMARATE
- Manufacturer
- Alembic Pharmaceuticals Limited
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot# 2405003360
- Exp Date: Jan 31
- 2026
UPCs (2)
- 0362332176304
- 0362332175307
Distribution
Distributed nationwide across the United States.
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