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Lower risk Drug recall · FDA · Published December 16, 2016

Pantoprazole Sodium Injections with Yellowish-Brown Powder Recalled

Aurobindo Pharma USA Inc recalls Pantoprazole Sodium 40mg injections with yellowish-brown powder. Discoloration may indicate contamination. Check NDC 55150-202-00 and lot CPO160028.

🇺🇸 FDA recall #D-0470-2017DrugAurobind: Aurobindo Pharma USA Inc ›
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Recalling firmAurobindo Pharma USA Inc666 Plainsboro Rd Ste 210 · Plainsboro, NJ 08536-3004
✎ GovInfoNow plain-language explainer

What happened, in plain English

Aurobindo Pharma USA Inc is recalling Pantoprazole Sodium for Injection 40mg vials that show discoloration. This discoloration could indicate contamination, which may pose a health risk if the medication is used. Read more at govinfonow.com/recall/42120-pantoprazole-sodium-injections-with-yellowish-brown-powder-recalled.

Source Summary by GovInfoNow · govinfonow.com/recall/42120-pantoprazole-sodium-injections-with-yellowish-brown-powder-recalled · Updated October 8, 2026 · FDA enforcement record: FDA #D-0470-2017

Cite this page

“Pantoprazole Sodium Injections with Yellowish-Brown Powder Recalled.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42120-pantoprazole-sodium-injections-with-yellowish-brown-powder-recalled. Based on FDA recall #D-0470-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0470-2017%22&limit=1).

Why it’s dangerous

The vials may contain yellowish-brown powder, which could indicate contamination. This discoloration might lead to health issues if the medication is administered without proper quality control.

Who’s affected

Patients prescribed Pantoprazole Sodium for Injection 40mg by a doctor who received the recalled vials (NDC 55150-202-00, lot CPO160028) are affected. Those using the product without medical supervision are not at risk.

How to tell if you have this one

Check for vials with yellowish-brown powder. The product has NDC 55150-202-00 and was manufactured in India for Auromedics Pharma LLC, lot CPO160028, expiring June 2018.

  • Brand
    Aurobind: Aurobindo Pharma USA Inc
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Vial Appearance

    Look for yellowish-brown powder in the vial. If present, do not use the product.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.6 years after the firm started it.

1. Firm started the recall: Dec 16, 201612. FDA classified it Class III: Feb 8, 201723. Published in FDA’s Enforcement Report: Feb 15, 201734. FDA terminated the recall: Jul 29, 2020420162020
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0470-2017 (December 16, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0470-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA