Drug FDA Class II Ongoing cGMP deviation

Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA Published Apr 16, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

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 Glenmark Pharmaceuticals Inc., USA or your place of purchase with questions, and see the source record below for full details.

Reason for recall

CGMP Deviations

Affected products (1)

Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.

SOLIFENACIN SUCCINATE · N/A

NDC: 68462-386, 68462-387, 68462-386-30, 68462-386-90, 68462-386-14, 68462-387-30, 68462-387-90, 68462-387-14

Lot codes: 17230762

Code info: Lot # 17230762, exp. date Mar-25

Affected areas

Nationwide

Timeline

Initiated

Mar 13, 2025
Published

Apr 16, 2025

Recall number: D-0317-2025
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.