FDA Drugs recall ·
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only… recall
- Recall number
- D-0462-2025
- Date
- (initiated May 19, 2025)
- Company / brand
- Glenmark Pharmaceuticals Inc., USA
750 Corporate Dr, Mahwah, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 6,759 Con - 90 bottle pack
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 17240195, Exp 01/31/2026.
Distribution
Nationwide USA and PR
States: Puerto Rico
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0462-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.