[pending] EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
Pending LLM rewrite. Source: FDA_DRUG D-0462-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
- Brand
- EZETIMIBE AND SIMVASTATIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 17240195
- Exp 01/31/2026.
UPCs (3)
- 0368462321300
- 0368462322307
- 0368462323304
Distribution
Distributed nationwide across the United States.
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- ModerateDr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Failed Excipient Specifications
FDA (Drugs) · 2021-11-10
- ModerateDr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Excipient Specification Failure
FDA (Drugs) · 2021-11-10
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