Alembic Pharmaceuticals LimiteddrugHigh PriorityActive

Fesoterodine Fumarate Recall

Fesoterodine Fumarate has been recalled due to failed impurities/degradation specifications: due to levels of 'diester impurity' exceeding the specification limit.. Consumers who purchased this product should stop using it immediately. Check the official FDA notice for specific lot numbers and return or disposal instructions.

By RecallRadar Editorial Team

Sourced from FDA. Last verified March 4, 2026.

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Key facts

Date announced: December 16, 2025
Source agency: FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

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

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand: Alembic pharmaceuticals limited
Category: drug
Source agency: FDA
Announced: December 16, 2025
Country: US
Status: Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot# 2405003360, Exp Date: Jan 31, 2026

#	Model
1	Lot# 2405003360, Exp Date: Jan 31, 2026

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

1## 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 Agency: FDA | Category: drug Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. What to do:
2Stop using the product if your lot/model matches.
3Check the FDA notice for specifics.
4Follow remedy instructions.

Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: December 16, 2025
Last reviewed by RecallRadar: March 4, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Lot# 2405003360, Exp Date: Jan 31, 2026.

What is the remedy for this recall?

## 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 Agency: FDA | Category: drug Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: Alembic Pharmaceuticals Limited recall hub and Food & Drug recall hub.