FDAClass IIIFebruary 20, 2019

Esomeprazole Magnesium Delayed-Release Capsules USP recall

Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only…

Why was Esomeprazole Magnesium Delayed-Release Capsules USP recalled?

Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

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) C800589, Exp 5/2019; C706058, Exp 03/2019 Lot #: b) C704873 Exp 02/2019; C800951, C800953 Exp 06/2019.

Product
Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only…
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
40,592, 90 and 1,000 count bottles
Distribution
Distributed Nationwide in the USA
Recall date
February 20, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls