Ezetimibe and Simvastatin tablets recalled for impurity specification failure
Glenmark Pharmaceuticals is recalling Ezetimibe and Simvastatin 10mg/40mg tablets (Lot 17240195) distributed nationwide due to out-of-specification impurity levels detected during stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall for a quality control issue detected during stability testing. The hazard consists of out-of-specification impurity levels (Anhydro Simvastatin degradation product), classified as a precautionary recall without reported adverse events.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Ezetimibe and Simvastatin tablets (10mg/40mg strength) due to out-of-specification impurity findings during stability testing. The affected lot is 17240195 with an expiration date of January 31, 2026, distributed nationwide in the United States and Puerto Rico.
During long-term stability testing, the related substances test showed that Anhydro Simvastatin levels exceeded acceptable specifications at the six-month time point. This degradation product indicates the product quality does not meet established standards.
Patients taking affected tablets should consult their healthcare provider or pharmacist to determine next steps. Do not stop taking medication without medical guidance. If you have this product, check the lot number (17240195) and expiration date (01/31/2026) on the bottle. Healthcare providers and pharmacists should remove affected product from shelves and inventory immediately.
The recalled product
- Product
- EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
- Brand
- EZETIMIBE AND SIMVASTATIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- impurity
- degradation
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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