CLASS II Drug recall · Reported 27 Nov 2013 · FDA Enforcement Report
Omeprazole Delayed-Release Capsules, USP, 20 mg recalled
Kremers Urban Pharmaceuticals is recalling Omeprazole Delayed-Release Capsules, USP, 20 mg, distributed in Kentucky, Tennessee. The recall was initiated on 16 Sep 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-009-2014
- FDA event ID
- 66218
- Recalling firm
- Kremers Urban Pharmaceuticals, Seymour, IN
- Brand
- Omeprazole
- Manufacturer
- Lannett Company, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Sep 2013
- FDA classified
- 20 Nov 2013
- Reported
- 27 Nov 2013
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 16 Sep 2013 | Recall initiated by company | |
| 20 Nov 2013 | Classified by FDA | +65 days |
| 27 Nov 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
KY & TN
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Which lots are affected?
Lot Number 59627; Expiration Date 02/2014
Where was it sold?
KY & TN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Kremers Urban Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2) recalled | Kremers Urban Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2) recalled | Kremers Urban Pharmaceuticals | Potency & Assay | Nationwide |
Other Omeprazole recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Omeprazole and Sodium Bicarbonate For Oral Suspension recalled | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-Release Capsules, 20 mg* recalledAcid Reducer | Dr. Reddy's Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prilosec (Omeprazole Magnesium) For Delayed-Release Oral recalledPrilosec | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Omeprazole Delayed Release Capsules, USP, 20 mg recalled | Golden State Medical Supply | Potency & Assay | PA, TX |