Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Excipient Specification Failure
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin 10 mg/10 mg tablets nationwide because the product was manufactured using an excipient that failed to meet conductivity specifications.
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 with no reported illnesses or injuries. The hazard is a manufacturing defect (failed excipient specification) that represents a quality-control issue rather than an immediate safety threat. The source text does not indicate that the excipient failure resulted in any reported harm.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ezetimibe and Simvastatin 10 mg/10 mg tablets distributed nationwide in the United States. The recall affects 90-count bottles (NDC 43598-742-90, lot L100256, expiration 01/2023) and 1000-count bottles (NDC 43598-742-10, lot L100257, expiration 01/2023). The product was manufactured using an excipient that was found to be out of specification for conductivity.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. The FDA has classified this as a Class II recall.
The recalled product
- Product
- EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
- Brand
- EZETIMIBE AND SIMVASTATIN
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
- failed-specifications
- excipient-defect
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) L100256
- exp 01/2023
- b) L100257
UPCs (4)
- 0343598745909
- 0343598742908
- 0343598743905
- 0343598744902
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · EZETIMIBE AND SIMVASTATIN
- ModerateEzetimibe and Simvastatin tablets recalled for impurity specification failure
FDA (Drugs) · 2025-06-18
- ModerateEzetimibe and Simvastatin Tablets Recalled for Defective Excipient and Foreign Tablets
FDA (Drugs) · 2021-11-17
- ModerateEzetimibe and Simvastatin Tablets Recalled for Excipient Specification Failure
FDA (Drugs) · 2021-11-17
- 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 category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27