Dietary Cholesterol Absorption Inhibitor, HMG-CoA Reductase Inhibitor
Where is Ezetimibe and Simvastatin made?
6 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 3 factories in India.
India 3
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Ascend Laboratories, LLC10 mg, 10 mg / 20 mg, 10 mg / 40 mg, 10 mg / 80 mg · NDC 67877-507, 67877-508, 67877-509 +1 | Alkem Laboratories LimitedMakes it, tests it and packages it | Baddi Solan, India | Problems found, fixed voluntarilyMar 2024 |
| Aurobindo Pharma Limited10 mg, 10 mg / 20 mg, 10 mg / 40 mg, 10 mg / 80 mg · NDC 59651-835, 59651-836, 59651-837 +1 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Dr. Reddy's Laboratories Inc.10 mg, 10 mg / 20 mg, 10 mg / 40 mg, 10 mg / 80 mg · NDC 43598-742, 43598-744, 43598-743 +1 | Dr. Reddy's Laboratories Inc. DBA Dr. Reddy's Laboratories Louisiana, LLCMakes it and tests it | Location not on file | Not inspected on record |
| Glenmark Pharmaceuticals Inc., USA10 mg, 10 mg / 20 mg, 10 mg / 40 mg, 10 mg / 80 mg · NDC 68462-321, 68462-322, 68462-323 +1 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Northstar Rx LLC.10 mg, 10 mg / 20 mg, 10 mg / 40 mg, 10 mg / 80 mg · NDC 16714-778, 16714-779, 16714-780 +1 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Organon LLC Vytorin10 mg, 10 mg / 20 mg, 10 mg / 40 mg, 10 mg / 80 mg · NDC 78206-174, 78206-175, 78206-176 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ezetimibe and Simvastatin in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-3984,50090-7047,50090-4772 - Golden State Medical Supply, Inc.:
51407-190,51407-191,51407-192,51407-193 - Physicians Total Care, Inc.:
54868-5250,54868-5187,54868-5189,54868-5259 - Rebel Distributors Corp..:
21695-325,21695-339,21695-827
Recalls
- May 19, 2025 · Class III · Glenmark Pharmaceuticals Inc., USA
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. - Oct 14, 2021 · Class II · Golden State Medical Supply Inc.
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity - Oct 14, 2021 · Class II · Golden State Medical Supply Inc.
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle - Oct 5, 2021 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle - Oct 5, 2021 · Class II · Dr. Reddy's Laboratories, Inc. · 4 recall notices
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity - Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.