Pantoprazole recalls

The FDA has published 26 recalls involving Pantoprazole since 2013. The latest was reported on 9 Sep 2026. Most were for manufacturing (cgmp) deviations. Aidapak Services has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls26since 2013

Last 12 months2reported

Class I14% of total

Ongoing3latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 1 0May 0 0 0Aug 1 0

Severity split

Class I 1 4%Class II 22 85%Class III 3 12%

Why pantoprazole is recalled

Companies

Brands

Pantoprazole Sodium1038%
Protonix14%

By year

202628%
2023415%
2022312%
202128%
202014%
201928%
201828%
201728%
201614%
2014623%

Ongoing pantoprazole recalls

3 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Pantoprazole Sodium in 0.9% Sodium Chloride Injection recalledPantoprazole Sodium	Baxter Healthcare	Manufacturing (CGMP) Deviations	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 recalls, newest first

26 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Pantoprazole Sodium in 0.9% Sodium Chloride Injection recalledPantoprazole Sodium	Baxter Healthcare	Manufacturing (CGMP) Deviations	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	Sterility	Nationwide
3 May 2023Drug	CLASS II	Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial recalled	Methapharm	Manufacturing (CGMP) Deviations	Nationwide
19 Apr 2023Drug	CLASS II	Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium	Hetero USA	Manufacturing (CGMP) Deviations	Nationwide
22 Feb 2023Drug	CLASS II	Pantoprazole 30MG IN NS, Syringe, antimetic recalled	Sentara Infusion Services	Sterility	Nationwide
30 Nov 2022Drug	CLASS II	Pantoprazole Sodium for Delayed-Release Oral Suspension*40 recalledPantoprazole Sodium	SUN Pharmaceutical Industries	Other	Nationwide
15 Jun 2022Drug	CLASS II	Pantoprazole Sodium for Injection, 40 mg/vial-dose vials recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	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. infusion only recalledPantoprazole Sodium	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
25 Mar 2020Drug	CLASS II	Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg recalled	Jubilant Cadista Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
23 Oct 2019Drug	CLASS II	Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg recalled	Jubilant Cadista Pharmaceuticals	Manufacturing (CGMP) Deviations	5 states
10 Apr 2019Drug	CLASS II	Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg* recalled	Jubilant Cadista Pharmaceuticals	Other	Nationwide
17 Oct 2018Drug	CLASS II	Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg* recalled	Jubilant Cadista Pharmaceuticals	Other	Nationwide
14 Feb 2018Drug	CLASS I	Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial recalledPantoprazole Sodium	AuroMedics Pharma	Particulate Matter	Nationwide
22 Mar 2017Drug	CLASS III	Protonix I.V. (pantoprazole sodium) for Injection recalled by PfizerProtonix	Pfizer	Potency & Assay	Nationwide
15 Feb 2017Drug	CLASS III	Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial recalledPantoprazole Sodium	Aurobindo Pharma USA	Other	Nationwide
21 Sep 2016Drug	CLASS II	Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg recalled	Aurobindo Pharma USA	Other	CA
18 Jun 2014Drug	CLASS II	Pantoprazole Sodium, Delayed-release tablets, USP dose packages recalled	Legacy Pharmaceutical Packaging	Packaging Defects	IN
29 Jan 2014Drug	CLASS II	Pantoprazole Sodium DR, Tablet, 20 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Pantoprazole Sodium DR Tablet, 20 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Pantoprazole Sodium DR, Tablet, 20 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Pantoprazole Sodium DR Tablet, 40 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Pantoprazole Sodium DR Tablet, 20 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
8 May 2013Drug	CLASS II	Pantoprazole Sodium Delayed Release Tablets USP, 40 mg recalled	Jubilant Cadista Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Pantoprazole?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.