The Recall Desk
ModerateFDA (Drugs)·D-0081-2022·Announced 2021-11-10

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.
Category
Drug — Prescription Drug / Manufacturing Defect
Hazard

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.

Part of a larger recall action

This product is one of 5 recalled by Dr. Reddy's Laboratories, 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 5 products in this recall →

Related recalls

Same brand · EZETIMIBE AND SIMVASTATIN

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · failed specifications

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