Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Failed Excipient Specifications
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin Tablets (10 mg/80 mg) 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 relates to a failed excipient specification (conductivity out of range), which is a manufacturing/quality control issue with uncertain clinical impact. There is no evidence of actual harm or high-risk contamination.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, in 30-count, 90-count, and 500-count bottles (NDCs 43598-745-30, 43598-745-90, and 43598-745-05) distributed nationwide in the United States. The recall was initiated because the product was manufactured using an excipient found to be out of specification for conductivity.
Patients who have filled a prescription for this medication should not discontinue use without consulting their healthcare provider. Patients with questions about this recall or who are experiencing any unusual symptoms should contact their physician immediately. Healthcare providers should advise patients to return unused portions of the affected product to their pharmacy.
The recalled product
- Product
- EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
- Brand
- EZETIMIBE AND SIMVASTATIN
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
- excipient-specification-failure
- failed-quality-control
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) L100160
- exp 01/2023 b) L100249
- exp 01/2023 c) L100250
- exp 01/2023
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 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
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