FDA Drug recall D-0251-2021
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc
- FDA Drug
- Class III
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class III recall of Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc by Sun Pharmaceutical Industries, citing failed Impurity/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0251-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-02-05 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40
Reason
Failed Impurity/Degradation Specifications
Identifiers
| ndc | 62756-129-40 |
|---|---|
| ndc | 62756-129-44 |
| ndc | 62756-129-45 |
| code_info | JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0251-2021%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.