Omeprazole Delayed-Release Capsules — Class II drug recall D-009-2014
Terminated recall by Kremers Urban Pharmaceuticals, Inc., reported 2013-11-27, distributed in KY, TN. Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the spec
| Recall number | D-009-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kremers Urban Pharmaceuticals, Inc., Seymour, IN, United States |
| Recall initiated | 2013-09-16 |
| Classified | 2013-11-20 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-05-09 |
| Distributed | KY, TN |
| Quantity | 3,867 bottles |
| NDC | 62175-0114, 62175-0114-32, 62175-0114-37, 62175-0114-46, 62175-0114-49, 62175-0118, 62175-0118-32, 62175-0118-37, 62175-0118-43, 62175-0118-46, 62175-0118-49, 62175-0136, 62175-0136-32, 62175-0136-37, 62175-0136-43, 62175-0136-46, 62175-0136-49 |
| Lot numbers | 59627 |
| Expiration dates | 2014-02 |
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 for recall
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-009-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.