← FDA ENFORCEMENT
D-0596-2025Class II
Baxter Healthcare Corporation
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Ongoing
Report date
2025-09-03
Distribution
U.S.A. Nationwide
Firm state
IL
Product quantity
13,000 containers
Initiated by
Voluntary: Firm initiated
Reason for recall
Discoloration
Product description
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.
Code / lot info
Lot #: 24A27G66, Exp 12/31/2025
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →