FDA recalls Baxter acetaminophen injection for discoloration defect
Baxter Healthcare Corporation is voluntarily recalling acetaminophen injection due to discoloration observed in the product. The recall affects 13,000 containers distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary recall with no reported illnesses or injuries. Discoloration in a prescription injectable product indicates a potential quality issue, but without evidence of actual harm, this falls within the moderate category per FDA guidelines for voluntary recalls without documented adverse health effects.
Plain-English summary
Baxter Healthcare Corporation is recalling acetaminophen injection 1000 mg/100 mL (10 mg/mL) in 100 mL Viaflo containers. Lot #24A27G66 (expiration December 31, 2025) is affected. Approximately 13,000 containers distributed across the United States are included in the recall.
The recall was issued due to discoloration observed in the product. Baxter Healthcare Corporation voluntarily initiated the recall on August 20, 2025. The firm is the manufacturer and original packager of this prescription drug.
Healthcare providers and patients with units from this lot should contact Baxter Healthcare Corporation located at 1 Baxter Parkway, Deerfield, Illinois 60015 for instructions regarding the recalled product.
The recalled product
- Product
- ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- ACETAMINOPHEN
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- discoloration
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 24A27G66
- Exp 12/31/2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ACETAMINOPHEN
- SevereFDA Recalls Acetaminophen Injection Due to Labeling Mix-up
FDA (Drugs) · 2024-08-28
- SevereAcetaminophen tablets incorrectly labeled with aspirin drug facts information
FDA (Drugs) · 2024-08-14
- ModerateExtra Strength Acetaminophen 500mg Tablets Recalled for Discoloration
FDA (Drugs) · 2024-07-03
- HighAcetaminophen Injection Recalled for Temperature Storage Abuse Nationwide
FDA (Drugs) · 2022-08-24
- ModerateAcetaminophen Oral Suspension Recalled Due to Contaminated Raw Ingredient
FDA (Drugs) · 2021-11-17
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27