Lansoprazole Tablet, Orally Disintegrating, Delayed Release
FDA Recall NDC 43598-561
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Lansoprazole (NDC 43598-561). A significant event, classified as Class II, was initiated on Jul 13, 2022 by Dr.reddys Laboratories Inc. The reported reason for this action was: "FAILED DISSOLUTION SPECIFICATIONS"
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 II Terminated
FAILED DISSOLUTION SPECIFICATIONS
Jul 13, 2022
Aug 03, 2022
2,639 cartons
Recall Profile & Regulatory Data
Event ID
90601
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 06, 2023
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856179, NDC 43598-561-78
Batch or Lot Expiration Information
Lot# Lot T2100515, Exp 01/2023
Affected Packages Involved in this Recall
43598-560-79Product
43598-560-78Product
43598-561-79Product
43598-561-78Product
4359856179Product
Class II Terminated
FAILED DISSOLUTION SPECIFICATIONS
Jul 13, 2022
Aug 03, 2022
2,892 cartons
Recall Profile & Regulatory Data
Event ID
90601
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 06, 2023
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78
Batch or Lot Expiration Information
Lot# Lot T2100514, Exp 01/2023
Affected Packages Involved in this Recall
43598-560-79Product
43598-560-78Product
43598-561-79Product
43598-561-78Product
4359856079Product
Class II Terminated
Failed Dissolution Specifications
Apr 15, 2022
May 11, 2022
252 Blister Packs
Recall Profile & Regulatory Data
Event ID
90021
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH
Termination Date
Nov 07, 2023
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.
Batch or Lot Expiration Information
Lot# : T2000645, Exp 07/2022
Affected Packages Involved in this Recall
43598-560-79Product
43598-560-78Product
43598-561-79Product
43598-561-78Product
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.
