FDA Drug recall D-009-2014

Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc

FDA Drug
Class II
terminated
Published 2013-11-27

On 2013-11-27 the FDA classified a Class II recall of Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc by Kremers Urban Pharmaceuticals, citing failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-009-2014
Classification	Class II
Status	terminated
Initiated	2013-09-16
Published	2013-11-27
Last updated	2026-09-13 11:51 UTC
Company	Kremers Urban Pharmaceuticals
Distribution	KY, TN

Product

Omeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-43

Reason

Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

Identifiers

ndc	62175-114-37
ndc	62175-114-32
ndc	62175-114-46
ndc	62175-114-49
ndc	62175-118-49
ndc	62175-118-32
ndc	62175-118-46
ndc	62175-118-37
ndc	62175-118-43
ndc	62175-136-32
ndc	62175-136-46
ndc	62175-136-37
ndc	62175-136-43
ndc	62175-136-49
code_info	Lot Number 59627; Expiration Date 02/2014

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-009-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.