CLASS II ONGOING Drug recall · Reported 19 Apr 2023 · FDA Enforcement Report
Pantoprazole Sodium Delayed Release Tablets USP 40mg recalled
Hetero USA is recalling Pantoprazole Sodium Delayed Release Tablets USP 40mg, distributed nationwide in the US. The recall was initiated on 14 Mar 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-0530-2023
- FDA event ID
- 91855
- Recalling firm
- Hetero USA, Piscataway, NJ
- Brand
- Pantoprazole Sodium
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Mar 2023
- FDA classified
- 11 Apr 2023
- Reported
- 19 Apr 2023
- Type
- N/A
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 14 Mar 2023 | Recall initiated by company | |
| 11 Apr 2023 | Classified by FDA | +28 days |
| 19 Apr 2023 | 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
CGMP Deviations: Discoloration
Product as listed by the FDA
Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
CGMP Deviations: Discoloration
Which lots are affected?
Lot #: PAN22542, Exp. Date: 9/2024
Where was it sold?
Nationwide within the United States
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.
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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 30MG IN NS, Syringe, antimetic recalled | Sentara Infusion Services | Sterility | Nationwide |