CLASS III Drug recall · Reported 17 Feb 2021 · FDA Enforcement Report
Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only recalled
SUN Pharmaceutical Industries is recalling Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only, distributed nationwide in the US. The recall was initiated on 5 Feb 2021 and the FDA has classified it as Class III.
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-0251-2021
- FDA event ID
- 87260
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Pantoprazole Sodium
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Feb 2021
- FDA classified
- 9 Feb 2021
- Reported
- 17 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 5 Feb 2021 | Recall initiated by company | |
| 9 Feb 2021 | Classified by FDA | +4 days |
| 17 Feb 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurity/Degradation Specifications
Which lots are affected?
JKU3595A, JKU3596A, JKU3597A, and JKU3629A; Exp 02/2021
Where was it sold?
Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 SUN Pharmaceutical Industries
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Tretinoin Cream USP, 0.05% tube recalledTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Tretinoin Cream UPS recalled by SUN Pharmaceutical IndustriesTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS III | Tretinoin Cream USP, 0.05% tube recalledTretinoin | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | 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 40mg per vial, Single dose vials recalledPantoprazole Sodium | BE Pharmaceuticals | Sterility | 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 |