Class III
Ongoing
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
This recall is currently active, issued June 18, 2025. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- May 19, 2025
- Posted
- June 18, 2025
- Recall Number
- D-0462-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6,759 Con - 90 bottle pack
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide USA and PR
Lot / Code Info
Lot #: 17240195, Exp 01/31/2026.
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