Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Failed Excipient Specifications
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin 10 mg/40 mg tablets because an excipient used in manufacturing failed conductivity specifications. The recall affects 11,590 bottles of 30-count and 3,585 bottles of 90-count packages distributed nationwide.
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 II recall involving failed excipient specifications with no reported illnesses or injuries. The hazard is a manufacturing defect in a non-active ingredient where the specific clinical impact is not stated in the source text, making this a precautionary/quality-control recall typical of Moderate severity.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ezetimibe and Simvastatin tablets, 10 mg/40 mg strength, in 30-count (NDC 43598-743-30) and 90-count (NDC 43598-743-90) bottles. The recall was initiated because the product was manufactured using an excipient that did not meet conductivity specifications.
The affected bottles include lot numbers L100158 (expiration 12/2022) and L100159 (expiration 12/2022). The product was distributed nationwide in the United States. A total of 11,590 bottles of the 30-count package and 3,585 bottles of the 90-count package are being recalled.
Patients taking this medication should consult their healthcare provider or pharmacist before discontinuing use. Consumers who have purchased affected bottles should contact their pharmacy or the manufacturer for further instructions on return or replacement.
The recalled product
- Product
- EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
- Brand
- EZETIMIBE AND SIMVASTATIN
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
- failed-excipient-specification
- out-of-specification-conductivity
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 (3)
- a) L100158
- exp 12/2022 b) L100159
- exp 12/2022
UPCs (4)
- 0343598745909
- 0343598742908
- 0343598743905
- 0343598744902
Distribution
Distributed nationwide across the United States.
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