Ezetimibe and Simvastatin Tablets Recalled for Defective Excipient and Foreign Tablets
Golden State Medical Supply Inc. is recalling specific lots of Ezetimibe and Simvastatin 10 mg/40 mg tablets because an excipient used in manufacturing failed to meet conductivity specifications, and some bottles were found to contain foreign tablets.
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 a Class II recall involving a defective excipient and foreign material in a prescription medication. The source text does not report any illnesses or injuries. While the presence of foreign tablets represents a quality and safety concern, no adverse events have been documented, making this a precautionary recall that falls under the Moderate category.
Plain-English summary
Golden State Medical Supply Inc. is recalling Ezetimibe and Simvastatin 10 mg/40 mg tablets distributed in the United States. The recall was initiated due to two quality issues: the product was manufactured using an excipient that failed to meet conductivity specifications, and some bottles were found to contain foreign tablets or capsules.
The recalled product includes: • 101 bottles of 90-count tablets, Lot GS038610, Expiration 01/2023 (NDC 51407-192-90) • 145 bottles of 500-count tablets, Lot GS038891, Expiration 01/2023 (NDC 51407-192-05)
The tablets were manufactured by Dr. Reddy's Laboratories LA LLC in Shreveport, Louisiana, and packaged by GSMS, Incorporated in Camarillo, California. The product was distributed to two distributors located in Arizona and Missouri.
Patients taking this medication should consult their healthcare provider or pharmacist before discontinuing use. Anyone who has purchased this product and has questions should contact Golden State Medical Supply Inc.
The recalled product
- Product
- EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
- Brand
- EZETIMIBE AND SIMVASTATIN
- Manufacturer
- Golden State Medical Supply Inc.
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 (4)
- a) Lot: GS038610
- Exp: 01/2023
- b) GS038891
- Exp: 1/2023
Distribution
Part of a larger recall action
This product is one of 2 recalled by Golden State Medical Supply Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · EZETIMIBE AND SIMVASTATIN
- LowEzetimibe and Simvastatin Tablets Recalled for Failed Impurity Specifications
FDA (Drugs) · 2025-06-18
- ModerateEzetimibe and Simvastatin Tablets Recalled for Excipient Specification Failure
FDA (Drugs) · 2021-11-17
- ModerateDr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Excipient Specification Failure
FDA (Drugs) · 2021-11-10
- 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 Failed Excipient Specifications
FDA (Drugs) · 2021-11-10
Same manufacturer · Golden State Medical Supply Inc.
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