FDAClass IIOctober 27, 2021

Omeprazole Delayed-Release Capsules recall: CGMP Deviations

Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1

Why was Omeprazole Delayed-Release Capsules recalled?

CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.

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?

BT001594C

Product
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
8,976 bottles
Distribution
Nationwide in the USA
Recall date
October 27, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls