CLASS III Drug recall · Reported 15 Feb 2017 · FDA Enforcement Report
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial recalled
Aurobindo Pharma USA is recalling Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, distributed nationwide in the US. The recall was initiated on 16 Dec 2016 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-0470-2017
- FDA event ID
- 75997
- Recalling firm
- Aurobindo Pharma USA, Plainsboro, NJ
- Brand
- Pantoprazole Sodium
- Manufacturer
- Eugia US LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Dec 2016
- FDA classified
- 8 Feb 2017
- Reported
- 15 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 16 Dec 2016 | Recall initiated by company | |
| 8 Feb 2017 | Classified by FDA | +54 days |
| 15 Feb 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Product as listed by the FDA
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
Where it was distributed
Nationwide in US
Questions about this recall
Is Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial recalled?
Yes. Aurobindo Pharma USA recalled Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial on 16 Dec 2016. The recall is Class III and its status is Terminated. Recall number D-0470-2017.
Why was it recalled?
Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
Which lots are affected?
Lot #: CPO160028, Exp. June 2018
Where was it sold?
Nationwide in US
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 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.
More recalls from Aurobindo Pharma USA
All 58| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
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 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 Sodium for Delayed-Release Oral Suspension*40 recalledPantoprazole Sodium | Sun Pharmaceutical Industries | Other | Nationwide |