FDAClass IIAugust 3, 2022

Lansoprazole Delayed-Release Orally Disintegrating recall: Failed Dissolution

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

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?

Lot T2100515, Exp 01/2023

Product
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
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
2,639 cartons
Distribution
Nationwide in the USA
Recall date
August 3, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls