Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) recall
FDA recall D-0596-2025 · initiated Aug 20, 2025
Baxter Healthcare Corporation recalled Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) in Aug 2025 — an FDA Class II recall (D-0596-2025) because Discoloration.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Discoloration
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 13,000 containers
Details
- 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.
- Recalling company
- Baxter Healthcare Corporation
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S.A. Nationwide
- Initiated
- Aug 20, 2025
- FDA report date
- Sep 3, 2025
Frequently asked
- Was Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) recalled?
- Baxter Healthcare Corporation recalled Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) in Aug 2025 — an FDA Class II recall (D-0596-2025) because Discoloration. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) recalled?
- Per the FDA enforcement record, the reason for recall D-0596-2025 was: Discoloration
- Is a recalled Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Acetaminophen Injection 1000 mg/100 mL (10 mg/mL) are affected?
- Distributed: U.S.A. Nationwide. The recall covers these lots — Lot #: 24A27G66, Exp 12/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0596-2025.