Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) recall
FDA recall D-0649-2024 · initiated Aug 1, 2024
Baxter Healthcare Corporation recalled Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) in Aug 2024 — an FDA Class I recall (D-0649-2024) because Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
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: 44,208 containers
Details
- Product
- Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
- Recalling company
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Aug 1, 2024
- FDA report date
- Sep 11, 2024
Frequently asked
- Was Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) recalled?
- Baxter Healthcare Corporation recalled Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) in Aug 2024 — an FDA Class I recall (D-0649-2024) because Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) recalled?
- Per the FDA enforcement record, the reason for recall D-0649-2024 was: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Is a recalled Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) 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. Most serious — a reasonable probability that use will cause serious harm or death. 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 Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # N008235, Exp 8/31/2024. 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-0649-2024.