Pantoprazole Sodium recalls

Pantoprazole Sodium products have been recalled 10 times, most recently on 9 Sep 2026. The recalling company is usually Sun Pharmaceutical Industries.

Total recalls10since 2017

Last 12 months2reported

Class I110% of total

Ongoing3latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 1Apr 0 0 0Jul 0 1

Severity split

Class I 1 10%Class II 7 70%Class III 2 20%

Why pantoprazole sodium is recalled

Companies

Product types

Stomach & Acid Reflux Medication10100%

By year

2026220%
2023220%
2022220%
2021220%
2018110%
2017110%

Ongoing pantoprazole sodium recalls

3 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Pantoprazole Sodium in 9% Sodium Chloride Injection recalledPantoprazole Sodium	Baxter Healthcare	Sterility	Nationwide
29 Apr 2026Drug	CLASS II	Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium	Hetero Labs Limited (Unit V)	Other	Nationwide
19 Apr 2023Drug	CLASS II	Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium	Hetero USA	Manufacturing (CGMP) Deviations	Nationwide

All pantoprazole sodium recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Pantoprazole Sodium in 9% Sodium Chloride Injection recalledPantoprazole Sodium	Baxter Healthcare	Sterility	Nationwide
29 Apr 2026Drug	CLASS II	Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium	Hetero Labs Limited (Unit V)	Other	Nationwide
20 Sep 2023Drug	CLASS II	Pantoprazole Sodium for Injection 40mg per vial, Single dose vials recalledPantoprazole Sodium	Be Pharmaceuticals Ag	Sterility	Nationwide
19 Apr 2023Drug	CLASS II	Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium	Hetero USA	Manufacturing (CGMP) Deviations	Nationwide
30 Nov 2022Drug	CLASS II	Pantoprazole Sodium for Delayed-Release Oral Suspension*40 recalledPantoprazole Sodium	Sun Pharmaceutical Industries	Other	Nationwide
11 May 2022Drug	CLASS II	Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg recalledPantoprazole Sodium	Torrent Pharma	Manufacturing (CGMP) Deviations	Nationwide
2 Jun 2021Drug	CLASS II	Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* recalledPantoprazole Sodium	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
17 Feb 2021Drug	CLASS III	Pantoprazole Sodium for Injection 40mg/vial For I.V recalledPantoprazole Sodium	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
14 Feb 2018Drug	CLASS I	Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial recalledPantoprazole Sodium	AuroMedics Pharma	Particulate Matter	Nationwide
15 Feb 2017Drug	CLASS III	Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial recalledPantoprazole Sodium	Aurobindo Pharma USA	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.