Lansoprazole Tablet, Orally Disintegrating
FDA Recall NDC 68382-771
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Lansoprazole (NDC 68382-771). A significant event, classified as Class II, was initiated on Dec 03, 2020 by Zydus Pharmaceuticals Usa 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
Dec 03, 2020
Dec 23, 2020
22,848 cartons
Recall Profile & Regulatory Data
Event ID
86925
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 20, 2022
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablets (10 x 10 unit-dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-772-77
Batch or Lot Expiration Information
Lot# M900412 December 2020 M904772 February 2021 M915745 October 2021
Affected Packages Involved in this Recall
68382-771-30Product
68382-771-77Product
68382-772-30Product
68382-772-77Product
Class II Terminated
Failed Dissolution Specifications
Dec 03, 2020
Dec 23, 2020
15,144 cartons
Recall Profile & Regulatory Data
Event ID
86925
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 20, 2022
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77
Batch or Lot Expiration Information
Lot# M915744 OCT 2021 M904770 FEB 2021
Affected Packages Involved in this Recall
68382-771-30Product
68382-771-77Product
68382-772-30Product
68382-772-77Product
Class II Terminated
Failed Dissolution Specification
Oct 27, 2020
Nov 11, 2020
6,840 units
Recall Profile & Regulatory Data
Event ID
86663
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Dec 20, 2022
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-771-77
Batch or Lot Expiration Information
Lot# M005681, EXP 3/2022
Affected Packages Involved in this Recall
68382-771-30Product
68382-771-77Product
68382-772-30Product
68382-772-77Product
Class II Terminated
Failed Dissolution Specification
Oct 27, 2020
Nov 11, 2020
7,908 units
Recall Profile & Regulatory Data
Event ID
86663
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Dec 20, 2022
Product Description
Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77
Batch or Lot Expiration Information
Lot# M005682, EXP 3/2022
Affected Packages Involved in this Recall
68382-771-30Product
68382-771-77Product
68382-772-30Product
68382-772-77Product
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.
