Recall: D-0462-2025

Class III - Minor Violations

Class IIIClassification

2025-05-19Initiated

OngoingStatus

Glenmark Pharmaceuticals Inc.,Firm

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

Reason

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.