Ezetimibe and Simvastatin Tablets recall
FDA recall D-0462-2025 · initiated May 19, 2025
Glenmark Pharmaceuticals Inc., USA recalled Ezetimibe and Simvastatin Tablets in May 2025 — an FDA Class III recall (D-0462-2025) because 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.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6,759 Con - 90 bottle pack
Details
- 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
- Recalling company
- Glenmark Pharms
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide USA and PR
- Initiated
- May 19, 2025
- FDA report date
- Jun 18, 2025
This recall is linked to a product we cover: Ezetimibe and Simvastatin →
Frequently asked
- Was Ezetimibe and Simvastatin Tablets recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Ezetimibe and Simvastatin Tablets in May 2025 — an FDA Class III recall (D-0462-2025) because 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Ezetimibe and Simvastatin Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0462-2025 was: 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.
- Is a recalled Ezetimibe and Simvastatin Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ezetimibe and Simvastatin Tablets are affected?
- Distributed: Nationwide USA and PR. The recall covers these lots — Lot #: 17240195, Exp 01/31/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0462-2025.