CLASS I ONGOING Drug recall · Reported 11 Sep 2024 · FDA Enforcement Report
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) recalled
Baxter Healthcare is recalling Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) per/mL) Sterile Single Dose, distributed nationwide in the US. The recall was initiated on 1 Aug 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0649-2024
- FDA event ID
- 95102
- Recalling firm
- Baxter Healthcare, Round Lake, IL
- Manufacturer
- Baxter Healthcare Corporation
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 1 Aug 2024
- FDA classified
- 30 Aug 2024
- Reported
- 11 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Blood Thinners
Timeline
| 1 Aug 2024 | Recall initiated by company | |
| 30 Aug 2024 | Classified by FDA | +29 days |
| 11 Sep 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Which lots are affected?
Lot # N008235, Exp 8/31/2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Heparin recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Heparin Sodium, 25,000 USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose | B. Braun Medical | Potency & Assay | Nationwide |
| Drug | CLASS II | Heparin Sodium Injection, USP, 20,000 USP units per mL recalledHeparin Sodium | Sagent Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Heparin Sodium, 25,000USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose | B. Braun Medical | Potency & Assay | Nationwide |
| Drug | CLASS II | Heparin/lido HCL/sodium Bicarb 100u/2mg/16.8mg/ML Syringe) recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Heparin Sodium 2,000, USP Units, per (2 USP Units/mL) recalled by PfizerHeparin Sodium | Pfizer | Sterility | Nationwide |