CLASS II Drug recall · Reported 3 May 2023 · FDA Enforcement Report
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial recalled
Methapharm is recalling Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, distributed nationwide in the US. The recall was initiated on 7 Apr 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-0540-2023
- FDA event ID
- 92113
- Recalling firm
- Methapharm, Coral Springs, FL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 7 Apr 2023
- FDA classified
- 21 Apr 2023
- Reported
- 3 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 7 Apr 2023 | Recall initiated by company | |
| 21 Apr 2023 | Classified by FDA | +14 days |
| 3 May 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Product as listed by the FDA
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial recalled?
Yes. Methapharm recalled Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial on 7 Apr 2023. The recall is Class II and its status is Completed. Recall number D-0540-2023.
Why was it recalled?
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Which lots are affected?
Lots: 220801; 220802; 220803 Exp. July 2024
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Pantoprazole recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 40mg per vial, Single dose vials recalledPantoprazole Sodium | Be Pharmaceuticals Ag | Sterility | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium | Hetero USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium for Delayed-Release Oral Suspension*40 recalledPantoprazole Sodium | Sun Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium for Injection, 40 mg/vial-dose vials recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |