CLASS II Drug recall · Reported 20 Sep 2023 · FDA Enforcement Report
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials recalled
BE Pharmaceuticals is recalling Pantoprazole Sodium for Injection 40mg per vial, Single dose vials, distributed nationwide in the US. The recall was initiated on 5 Sep 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1148-2023
- FDA event ID
- 92968
- Recalling firm
- BE Pharmaceuticals, Zug
- Brand
- Pantoprazole Sodium
- Manufacturer
- BE Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2023
- FDA classified
- 11 Sep 2023
- Reported
- 20 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 5 Sep 2023 | Recall initiated by company | |
| 11 Sep 2023 | Classified by FDA | +6 days |
| 20 Sep 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
Which lots are affected?
Lots: (a) GSC04002A, GSC04003A, GSC04004A, GSC04006A, Exp Mar-2024; GSC05001A, GSC05006A, GSC05007A, Exp April-2024; GSC10003A, GSC10005A Exp Sep-2024;GSC06004A, GSC06005A, Exp May-2024; GSC07001A, GSC07007A, GSC07008A, GSC07009A, Exp Jun-2024; GSC08001A, Exp Jul-2024; GSC05009A, Exp Apr-2024; (b) GSC04005A, Exp Mar-2024; GSC06003A, Exp May-2024; GSC10001A, Exp Sep-2024; GSC07006A,Exp Jun-2024; GSC08002A, Exp Jul-2024; GSD02012A, Exp Jan-2025; GSD03005A, GSD03008A, Exp Feb-2025;
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from BE Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fosaprepitant for Injection 150 mg per vial recalledFosaprepitant | BE Pharmaceuticals | Sterility | Nationwide |
Other Pantoprazole recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pantoprazole Sodium in 0.9% Sodium Chloride Injection recalledPantoprazole Sodium | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium | Hetero Labs Limited (Unit V) | Other | Nationwide |
| Drug | CLASS II | Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial recalled | Methapharm | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium | Hetero USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pantoprazole 30MG IN NS, Syringe, antimetic recalled | Sentara Infusion Services | Sterility | Nationwide |