Solifenacin Succinate Tablets Recalled Due to Manufacturing Deviations
Glenmark Pharmaceuticals Inc., USA is recalling Solifenacin Succinate 5mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and affects 30-count and 90-count bottles distributed across the U.S.
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: This is an FDA Class II recall for CGMP deviations (manufacturing/process problems) with no reported illnesses or injuries. Class II recalls are generally moderate in severity when they involve manufacturing issues rather than contamination or hazardous defects.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Solifenacin Succinate 5mg tablets in two package sizes: 30-count bottles (NDC# 68462-386-30) and 90-count bottles (NDC# 68462-386-90). The recall applies to bottles with lot numbers 17232395 and 17232400, both with expiration dates of November 2025. The recall covers all U.S. nationwide distribution.
The reason for this recall is CGMP deviations—manufacturing process issues that do not meet federal standards. The manufacturer initiated the recall voluntarily on March 13, 2025, and the FDA classified it as Class II on April 8, 2025.
Consumers who have been prescribed this medication should contact their healthcare provider or pharmacist before discontinuing use. Patients should not stop taking their medication without medical guidance. Healthcare providers and pharmacies should quarantine affected inventory and contact their suppliers for return instructions.
For more information, consumers and healthcare providers can contact the FDA or Glenmark Pharmaceuticals Inc., USA.
The recalled product
- Product
- SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCINATE)
- Brand
- SOLIFENACIN SUCCINATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription Medication
- 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 (4)
- 30 count bottle: 17232395
- exp. date Nov-25 17232400
- exp. date Nov-25 90-count bottle: 17232395
- exp. date Nov-25
UPCs (1)
- 0368462386309
Distribution
Distributed nationwide across the United States.
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