FDAClass IIApril 6, 2022

Lansoprazole Delayed-Release Capsules recall: Failed Dissolution

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.…

Why was Lansoprazole Delayed-Release Capsules recalled?

Failed Dissolution Specifications; during long term stability testing.

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 # a) C2103093, Exp. 12/2023; b)C2103092, Exp. 12/2023.

Product
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.…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
8,352 bottles (30-count), 1,368 bottles (90-count)
Distribution
Nationwide in the USA
Recall date
April 6, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls