Ezetimibe and Simvastatin Tablets Recalled for Failed Impurity Specifications
Glenmark Pharmaceuticals Inc., USA is recalling Ezetimibe and Simvastatin Tablets (10mg/40mg) due to out-of-specification results for related substances in a stability study. The recall affects approximately 6,759 bottles distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall by the agency's own classification. Class III recalls are by definition unlikely to cause adverse health consequences, and no illnesses or injuries have been reported. The issue is a failed specification detected during stability testing rather than a direct safety hazard.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Ezetimibe and Simvastatin Tablets, 10mg/40mg strength, NDC 68462-323-90, due to failed impurity specifications. During a long-term stability study, testing at the six-month time point found that Anhydro Simvastatin levels were out of specification for the related substances test.
The recalled product consists of approximately 6,759 bottles (90-count packs) with Lot #17240195 and expiration date 01/31/2026. Distribution was nationwide in the USA and Puerto Rico.
Patients currently taking this medication should consult their healthcare provider or pharmacist about whether they have received affected product and what steps to take. Healthcare providers and pharmacists should check inventory against the lot number and NDC provided.
This is a Class III recall. The FDA is monitoring the situation for any adverse health events.
The recalled product
- Product
- EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
- Brand
- EZETIMIBE AND SIMVASTATIN
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
- impurity-out-of-specification
- degradation-product
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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