Recalls / Class II
Class IID-0333-2025
Product
Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430.
- Brand name
- Solifenacin Succinate
- Generic name
- Solifenacin Succinate
- Active ingredient
- Solifenacin Succinate
- Route
- Oral
- NDCs
- 68462-386, 68462-387
- FDA application
- ANDA209239
- Affected lot / code info
- 30 count bottle: 17232395, exp. date Nov-25 17232400, exp. date Nov-25 90-count bottle: 17232395, exp. date Nov-25
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- N/A
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-03-13
- FDA classified
- 2025-04-08
- Posted by FDA
- 2025-04-16
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0333-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.