Esomeprazole Magnesium Capsule, Delayed Release
FDA Recall NDC 43598-509
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Esomeprazole Magnesium (NDC 43598-509). A significant event, classified as Class III, was initiated on Apr 24, 2020 by Dr. Reddy's Laboratories Inc. The reported reason for this action was: "Discoloration: product contains brown pellets"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Discoloration: product contains brown pellets
Apr 24, 2020
May 06, 2020
1752 bottles
Recall Profile & Regulatory Data
Event ID
85557
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
May 13, 2022
Product Description
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
Batch or Lot Expiration Information
Lot# : C900642, Exp. 06/2020
Affected Packages Involved in this Recall
43598-509-30Product
43598-509-90Product
43598-509-10Product
43598-510-30Product
43598-510-90Product
43598-510-10Product
Class III Terminated
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Feb 06, 2019
Feb 20, 2019
40,592, 90 and 1,000 count bottles
Recall Profile & Regulatory Data
Event ID
82065
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jan 26, 2021
Product Description
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA.
Batch or Lot Expiration Information
Lot# : a) C800589, Exp 5/2019; C706058, Exp 03/2019
Lot# : b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.
Affected Packages Involved in this Recall
43598-509-30Product
43598-509-90Product
43598-509-10Product
43598-510-30Product
43598-510-90Product
43598-510-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
