Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0317-2025·Announced 2025-04-16

Solifenacin succinate tablets recalled nationwide for manufacturing practice deviations

Glenmark Pharmaceuticals is recalling solifenacin succinate 10mg tablets nationwide due to manufacturing process deviations. The voluntary recall affects specific lot numbers distributed across the United States.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The recall is voluntary and precautionary in nature, addressing manufacturing quality control deviations rather than confirmed product harm.

Plain-English summary

Glenmark Pharmaceuticals Inc., USA is recalling Solifenacin Succinate Tablets 10MG distributed nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected product includes 30-count and 90-count bottles with lot number 17230762 and an expiration date of March 2025 (NDC# 68462-387-30 and 68462-387-90).

The manufacturer voluntarily initiated this recall on March 13, 2025. The FDA classified this as a Class II recall, which the agency issues when a drug product defect may cause adverse health consequences or death.

Patients taking this medication should contact their healthcare provider or pharmacist for guidance on whether their specific medication is affected by this recall.

The recalled product

Product: SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCINATE)
Brand: SOLIFENACIN SUCCINATE
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Category: Drug
Hazard: cgmp-deviation

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 (2)

Lot # 17230762
exp. date Mar-25

UPCs (1)

0368462386309

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 39 products in this recall →

Same brand · SOLIFENACIN SUCCINATE

Moderate
Solifenacin Succinate Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2025-04-16

Same manufacturer · Glenmark Pharmaceuticals Inc., USA

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