FDAClass IIDecember 23, 2020

Lansoprazole Delayed-Release Orally Disintegrating recall: Failed Dissolution

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

Why was Lansoprazole Delayed-Release Orally Disintegrating recalled?

Failed Dissolution Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

M900412 December 2020 M904772 February 2021 M915745 October 2021

Product
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
Recalling firm
Zydus Pharmaceuticals (USA) Inc
Quantity
22,848 cartons
Distribution
Nationwide
Recall date
December 23, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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