Food, drugs, devices › SUN PHARMACEUTICAL INDUSTRIES INC
Drug recall: Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. C
SUN PHARMACEUTICAL INDUSTRIES INC (Princeton, NJ) initiated this drug recall on 5 Feb 2021; FDA lists 1 product record under event 87260, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 21% of the 299 drug enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 3 Nov 2021. Initiation: voluntary: firm initiated. SUN PHARMACEUTICAL INDUSTRIES INC has 94 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ.
Reason for recall
"Failed Impurity/Degradation Specifications"
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0251-2021 | 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 | 20,475 vials | Class III | Terminated | 17 Feb 2021 |
Context
Other enforcement events for SUN PHARMACEUTICAL INDUSTRIES INC
All 94 events for SUN PHARMACEUTICAL INDUSTRIES INC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurity/Degradation Specifications"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Nov 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.