Recalls / Class III
Class IIID-0462-2025
Product
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
- Brand name
- Ezetimibe And Simvastatin
- Generic name
- Ezetimibe And Simvastatin
- Active ingredients
- Ezetimibe, Simvastatin
- Route
- Oral
- NDCs
- 68462-321, 68462-322, 68462-323, 68462-324
- FDA application
- ANDA208699
- Affected lot / code info
- Lot #: 17240195, Exp 01/31/2026.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 6,759 Con - 90 bottle pack
- Distribution pattern
- Nationwide USA and PR
Timeline
- Recall initiated
- 2025-05-19
- FDA classified
- 2025-06-10
- Posted by FDA
- 2025-06-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0462-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.