Pantoprazole Sodium for Injection 40mg/vial For I — Class III drug recall D-0251-2021
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2021-02-17, distributed nationwide. Failed Impurity/Degradation Specifications
| Recall number | D-0251-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2021-02-05 |
| Classified | 2021-02-09 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2021-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 20,475 vials |
| Reason classes | specification failure |
| NDC | 62756-0129, 62756-0129-40, 62756-0129-44, 62756-0129-45 |
| Expiration dates | 2021-02 |
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 for recall
Failed Impurity/Degradation Specifications
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-0251-2021. 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.