Lansoprazole Capsule, Delayed Release
FDA Recall NDC 55111-398
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 Lansoprazole (NDC 55111-398). A significant event, classified as Class II, was initiated on Mar 23, 2022 by Dr.reddy's Laboratories Ltd.. The reported reason for this action was: "Failed Dissolution Specifications; during long term stability testing."
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
March 2022 Class II Recall: Failed Dissolution Specifications; during long term stability testing.
Recall Number
Class II Terminated
Failed Dissolution Specifications; during long term stability testing.
Mar 23, 2022
Apr 06, 2022
8,352 bottles (30-count), 1,368 bottles (90-count)
Recall Profile & Regulatory Data
Event ID
89871
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
Feb 02, 2024
Product Description
Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India
Batch or Lot Expiration Information
Lot# a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.
Affected Packages Involved in this Recall
55111-398-30Product
55111-398-60Product
55111-398-90Product
55111-398-01Product
55111-398-05Product
55111-398-79Product
55111-399-30Product
55111-399-60Product
55111-399-90Product
55111-399-01Product
55111-399-05Product
55111-399-79Product
March 2022 Class II Recall: Failed Dissolution Specifications; during long term stability testing.
Recall Number
Class II Terminated
Failed Dissolution Specifications; during long term stability testing.
Mar 23, 2022
Apr 06, 2022
7,703 bottles
Recall Profile & Regulatory Data
Event ID
89871
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
Feb 02, 2024
Product Description
Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.
Batch or Lot Expiration Information
Lot# C2102911, Exp. 12/2023
Affected Packages Involved in this Recall
55111-398-30Product
55111-398-60Product
55111-398-90Product
55111-398-01Product
55111-398-05Product
55111-398-79Product
55111-399-30Product
55111-399-60Product
55111-399-90Product
55111-399-01Product
55111-399-05Product
55111-399-79Product
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.
