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Drug FDA Class II Ongoing Quality

Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.

Baxter Healthcare Corporation Published Sep 3, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Baxter Healthcare Corporation or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Discoloration

Affected products (1)

Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), packaged in 100 mL Viaflo container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in Ireland, NDC 36000-306-60.

ACETAMINOPHEN · 13,000 containers

NDC: 36000-306, 36000-372, 36000-306-60, 36000-372-40
Code info: Lot #: 24A27G66, Exp 12/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 20, 2025
  2. Published
    Sep 3, 2025
Recall number
D-0596-2025
Agency
U.S. Food and Drug Administration
Country
US

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.