FDA Recall D-0596-2025
Baxter Healthcare Corporation · Deerfield, IL
Class II Ongoing 267 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
Discoloration
Recall record
- Recall number
D-0596-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S.A. Nationwide
- Recall initiated
- 2025-08-20
- Classified by FDA Center
- 2025-08-22
- FDA published
- 2025-09-03
- Recalling firm
- Baxter Healthcare Corporation
- Firm location
- Deerfield, IL
Drug identification
- Brand name(s)
- ACETAMINOPHEN
- Generic name(s)
- ACETAMINOPHEN
- Manufacturer(s)
- Baxter Healthcare Corporation
- NDC(s)
36000-306, 36000-372- Route(s)
- INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.