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Lower risk Drug recall · FDA · Published August 20, 2025

Baxter Acetaminophen Injection Recall: Discoloration Hazard

Baxter Healthcare recalls acetaminophen injection with discoloration risk. Check product details to determine if affected. Stop using if discoloration observed.

🇺🇸 FDA recall #D-0596-2025DrugBaxter Healthcare ›
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Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer

What happened, in plain English

Baxter Healthcare is recalling acetaminophen injection products that may have discoloration. This discoloration could indicate a potential issue with the product's safety, though the specific risk is not detailed in the recall notice. Read more at govinfonow.com/recall/31861-baxter-acetaminophen-injection-recall-discoloration-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/31861-baxter-acetaminophen-injection-recall-discoloration-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #D-0596-2025

Cite this page

“Baxter Acetaminophen Injection Recall: Discoloration Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31861-baxter-acetaminophen-injection-recall-discoloration-hazard. Based on FDA recall #D-0596-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0596-2025%22&limit=1).

Why it’s dangerous

Discoloration in the injection may indicate a problem with the product's stability or quality. However, the recall does not specify the exact risk or how discoloration could affect safety.

Who’s affected

Prescription holders of acetaminophen injection 1000 mg/100 mL (10 mg/mL) in 100 mL Viaflo containers. Patients using this medication for pain or fever relief are most at risk if discoloration is present.

How to tell if you have this one

Check for discoloration in the 100 mL Viaflo container. The product is labeled as acetaminophen injection 1000 mg/100 mL (10 mg/mL), prescription-only, made in Ireland with NDC 36000-306-60.

  • Brand
    Baxter Healthcare
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check for Discoloration

    Inspect the injection for any discoloration before use. If discoloration is 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: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 14 days after the firm started it.

1. Firm started the recall: Aug 20, 202512. FDA classified it Class II: Aug 22, 202523. Published in FDA’s Enforcement Report: Sep 3, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

What should I do if I have discoloration?

Do not use the product if discoloration is observed. Contact your healthcare provider for further instructions.

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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-0596-2025 (August 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0596-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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