Dr. Reddy's Laboratories, Inc.: Drug Recall

Recall Details

Recall Number

D-0085-2022

Classification

Class II

Product Type

Drug

Recalling Firm

Dr. Reddy's Laboratories, Inc.

Status

Terminated

Date Initiated

10/05/2021

Location

Princeton, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

696 bottles

Reason for Recall

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

Product Description

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA NDC 43598-743-05

Distribution Pattern

Nationwide in the US

Other Recalls by Dr. Reddy's Laboratories, Inc.

• Class III: Low Risk 11/11/2025
  Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
• Class II: Risk 09/26/2025
  Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
• Class II: Risk 06/30/2025
  Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
• Class I: Dangerous 03/13/2025
  LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
• Class III: Low Risk 11/22/2024
  Failed Impurities/Degradation Specifications

View all recalls by Dr. Reddy's Laboratories, Inc. →