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.
What this means for you
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.
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