The Recall Desk
ModerateFDA (Drugs)·D-0082-2022·Announced 2021-11-10

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

Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin Tablets (10 mg/20 mg) nationwide because the product was manufactured using an excipient that failed 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: The FDA classified this as a Class II recall. The source text does not report any illnesses, injuries, or deaths related to the failed excipient specifications. The hazard is a manufacturing defect (out-of-specification excipient conductivity) without reported patient harm, making this a precautionary recall meeting the Moderate threshold.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, distributed nationwide in the United States. The recall affects 30-count bottles (NDC 43598-744-30, lot numbers L100298 and L100304, expiration 01/2023) and 90-count bottles (NDC 43598-744-90, lot number L100235, expiration 01/2023).

The tablets are being recalled because they were manufactured using an excipient that failed to meet conductivity specifications. The product was manufactured by Dr. Reddy's Laboratories LA LLC in Shreveport, Louisiana, and distributed by Dr. Reddy's Laboratories Inc. in Princeton, New Jersey.

Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. Do not stop taking your medication without speaking to a healthcare professional first.

The recalled product

Product
EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
Brand
EZETIMIBE AND SIMVASTATIN
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Prescription Cholesterol-Lowering Medication
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) L100298 and L100304
  • exp 01/2023 b) L100235
  • 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 →

Related recalls

Same brand · EZETIMIBE AND SIMVASTATIN

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

See all →