Pantoprazole Sodium Delayed-Release Tablets — Class II drug recall D-0506-2021
Terminated recall by Cardinal Health Inc., reported 2021-06-02, distributed in FL, GA, SC. CGMP Deviations: Intermittent exposure to temperature excursion during storage.
| Recall number | D-0506-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2021-03-15 |
| Classified | 2021-05-24 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2024-06-17 |
| Distributed | FL, GA, SC |
| Quantity | 4 bottles |
| Reason classes | cgmp, temperature control |
| NDC | 62175-0180, 62175-0180-43, 62175-0180-46, 62175-0617, 62175-0617-43, 62175-0617-46, 62175-0618, 62175-0618-43, 62175-0618-46 |
Product
Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA
Reason for recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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-0506-2021. 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.