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Drug FDA Class III Ongoing Failed specifications

Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30

Alembic Pharmaceuticals Limited Published Nov 26, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Alembic Pharmaceuticals Limited or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Diester Impurity · primary

Affected products (1)

Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30

FESOTERODINE FUMARATE · 4,884 30-count bottles

NDC: 62332-175, 62332-176, 62332-175-30, 62332-175-90, 62332-175-91, 62332-175-10, 62332-176-30, 62332-176-90, 62332-176-91, 62332-176-10, 2405006633
Lot codes: 2405006633
Code info: Lot # 2405006633, Exp Date: 03/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 10, 2025
  2. Published
    Nov 26, 2025
Recall number
D-0156-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.