NDC 43598-745

Ezetimibe and Simvastatin 10 mg / 80 mg tablet

Where it's made

Factory	Where	Role	Last FDA inspection
Dr. Reddy's Laboratories Inc. DBA Dr. Reddy's Laboratories Louisiana, LLC	Location not on file	Makes it and tests it	Not inspected on record

Oct 5, 2021 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Lots: a) L100256, exp 01/2023; b) L100257, exp 01/2023
Oct 5, 2021 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Lots: a) L100298 and L100304, exp 01/2023 b) L100235, exp 01/2023
Oct 5, 2021 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Lots: a) L100160, exp 01/2023 b) L100249, exp 01/2023 c) L100250, exp 01/2023
Oct 5, 2021 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Lots: a) L100158, exp 12/2022 b) L100159, exp 12/2022
Oct 5, 2021 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Lots: L100208, exp 01/2023

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Generic drug: Ezetimibe and Simvastatin: every company that makes it
Form: tablet, oral
Strength: 10 mg / 80 mg
Approval: ANDA ANDA200909
On the market since: Nov 20, 2018
Package NDCs: 43598-745-05 43598-745-30 43598-745-90
Official label: DailyMed (National Library of Medicine), updated Jul 18, 2025

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