The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0085-2022·Announced 2021-11-10

Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Failed Excipient Specifications

Dr. Reddy's Laboratories is recalling 696 bottles of Ezetimibe and Simvastatin Tablets (10 mg/40 mg) distributed nationwide due to failed excipient specifications and the presence of foreign tablets in bottles.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 hazards—failed excipient specifications and presence of incorrect tablet strengths—represent quality and manufacturing control issues rather than documented harm or high-risk contamination. The recall is precautionary in nature.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500-count bottles (NDC 43598-743-05, Lot L100208, expiration 01/2023). The recall affects 696 bottles distributed nationwide in the United States.

The product was manufactured using an excipient (an inactive ingredient) that failed to meet conductivity specifications. Additionally, some bottles were found to contain foreign tablets identified as Ezetimibe and Simvastatin 10 mg/10 mg, which are not the correct strength for this recall lot.

Consumers who have received this product should stop taking it and contact their pharmacy or healthcare provider. Patients should not discontinue their cholesterol-lowering medication without medical guidance and should obtain a replacement from their pharmacy or contact Dr. Reddy's Laboratories, Inc. for assistance.

The recalled product

Product
EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
Brand
EZETIMIBE AND SIMVASTATIN
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Pharmaceutical
Hazard
Affected units
696

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 (2)

  • L100208
  • exp 01/2023

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 →

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