Recalls / Class II
Class IID-0596-2025
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.
- Brand name
- Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Intravenous
- NDCs
- 36000-306, 36000-372
- FDA application
- ANDA214331
- Affected lot / code info
- Lot #: 24A27G66, Exp 12/31/2025
Why it was recalled
Discoloration
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 13,000 containers
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2025-08-20
- FDA classified
- 2025-08-22
- Posted by FDA
- 2025-09-03
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0596-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.