Quick Facts at a Glance
- Recall Date
- December 16, 2025
- Hazard Level
- HIGH
- Brands
- FESOTERODINE FUMARATE, Alembic Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- FESOTERODINE FUMARATE, Alembic Pharmaceuticals
- Product type
- Fesoterodine Fumarate Tablets
- Model numbers
- Lot# 2405003360, Exp Date: Jan 31, 2026
- UPC codes
- 62332-175, 62332-176, 62332-175-30, 62332-175-90, 62332-175-91, 62332-175-10, 62332-176-30, 62332-176-90 +3 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 16, 2025
Reported by FDA DRUG
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Alembic Pharmaceuticals Limited or your healthcare provider for guidance
About This Product
Fesoterodine Fumarate is a medication used to treat overactive bladder symptoms such as urgency and frequency of urination. Consumers typically buy this medication to manage these urinary conditions, often prescribed by healthcare professionals.
Why This Is Dangerous
The recall involves high levels of a chemical impurity known as 'Diester Impurity,' which can pose health risks if ingested. This impurity exceeds the safety specifications set for the medication and necessitates the recall.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should stop using the medication immediately, which could lead to the need for alternative treatments. The recall may cause inconvenience for those relying on the medication for managing their condition.
Practical Guidance
How to identify if yours is affected
- Check the lot number on your medication packaging.
- Verify the expiration date, which should be January 31, 2026.
- If the lot number matches 2405003360, your product is affected.
Where to find product info
You can find the lot number on the bottle label or packaging of the tablets.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Contact the company again using their customer service number.
- File a complaint with the FDA if no response is received.
How to prevent similar issues
- Look for medications with clear labeling and impurity testing certifications.
- Consult healthcare providers for recommendations on safe alternatives.
- Research recalls and safety alerts for medications regularly.
Documentation advice
Document any communications with Alembic Pharmaceuticals and keep copies of receipts or purchases related to the product.
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Product Details
The recall involves Fesoterodine Fumarate, Extended-release Tablets, 8 mg, sold in 30-tablet bottles. The affected lot number is 2405003360, with an expiration date of January 31, 2026. Products were manufactured in Gujarat, India, and distributed across the U.S. and Puerto Rico.
Key Facts
- Recalled due to high levels of a chemical impurity
- Stop using the product immediately
- Consult healthcare providers for further guidance
- Distributed nationwide in the U.S. and Puerto Rico
- Affected lot number: 2405003360
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Safety Guide
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