Solifenacin Succinate Tablets Recalled Nationwide for Manufacturing Deviations
Glenmark Pharmaceuticals is recalling Solifenacin Succinate 5mg tablets nationwide due to manufacturing quality deviations. The affected bottles are 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: This is an FDA Class II voluntary recall for Current Good Manufacturing Practice (CGMP) deviations. No illnesses, injuries, or deaths have been reported, and the recall is precautionary in nature to address manufacturing quality control issues.
Plain-English summary
Glenmark Pharmaceuticals Inc. USA is recalling Solifenacin Succinate 5mg tablets distributed across the United States. The recall affects 30-count bottles (NDC 68462-386-30) and 90-count bottles (NDC 68462-386-90) manufactured by Glenmark Pharmaceuticals Limited in Pithampur, India. The affected bottles have lot numbers 17232395 and 17232400 with expiration dates of November 2025.
The recall was initiated voluntarily by the firm due to Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II. The recall was initiated on March 13, 2025.
Patients currently using the recalled product should consult with their healthcare provider about obtaining a replacement or alternative medication. Healthcare providers and pharmacies should remove the affected product from inventory. Anyone with questions about the recall can contact the recalling firm for additional information.
The recalled product
- Product
- SOLIFENACIN SUCCINATE (SOLIFENACIN SUCCINATE)
- Brand
- SOLIFENACIN SUCCINATE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Oral Tablet
- Hazard
- manufacturing-defect
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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