August 2025 FDA Recall Acetaminophen by Baxter Healthcare Corporation
D-0596-2025 - Discoloration
This Class II drug recall was voluntarily initiated by Baxter Healthcare Corporation on August 20, 2025 for the product Acetaminophen. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0596-2025
Discoloration
08-20-2025
09-03-2025
13,000 containers
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# : 24A27G66, Exp 12/31/2025
