Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Baxter Heparin Sodium Injection Recalled for Microbial Contamination

Agency Publication Date: August 30, 2024
Share:
Sign in to monitor this recall

Summary

Baxter Healthcare Corporation has recalled 44,208 containers of its Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL. This recall was issued because the product was found to have microbial contamination, specifically endotoxin testing results that were outside of acceptable limits. This sterile injection is typically provided in a 1,000 mL single-dose container for medical use.

Risk

Injecting a product contaminated with endotoxins can cause severe medical complications, including high fever, chills, shaking, and systemic inflammation that can lead to life-threatening sepsis.

What You Should Do

  1. This recall affects Baxter USA Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), sold in 1000 mL Sterile Single Dose Containers. Affected units are identified by NDC 0338-0433-04 and lot number N008235 with an expiration date of 8/31/2024.
  2. Stop using the recalled product immediately.
  3. Contact Baxter Healthcare Corporation or your distributor to arrange for the return of any remaining affected product.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional assistance.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL)by Baxter USA
Variants: 1000 mL Sterile Single Dose Container, Rx Only
Lot Numbers:
N008235 (Exp 8/31/2024)
NDC:
0338-0433-04

Recall #: D-0649-2024

Product Images

Label, Heparin Sodium in 0.9% Sodium Chloride Injection

Label, Heparin Sodium in 0.9% Sodium Chloride Injection

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95102
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Hospitals; Infusion centers; Surgical centers; Wholesalers
Manufactured In: United States
Units Affected: 44,208 containers
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.