Heparin Sodium Injection Recalled Due to Lack of Sterility Assurance

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for heparin sodium injection, USP, 1mL/vial. The affected batch has been identified as Lot CU03232A (expires January 2028), containing 251 000 vials.
• The recall was initiated by Shenzhen Techdow Pharmaceutical Co, Ltd due to a lack of assurance of sterility, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Heparin sodium injection is used to prevent and treat blood clots.

The FDA has issued a Class II recall for heparin sodium injection, USP, 1mL/vial, affecting 251 000 vials. This product is being recalled by Shenzhen Techdow Pharmaceutical Co, Ltd based in Shenzhen, China. The recall was initiated on October 1, 2026, and received a Class II classification on October 16, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to the product’s lack of sterility assurance. This issue affects Lot CU03232A, which will expire in January 2028. Shenzhen Techdow Pharmaceutical sent out a public notice via letter; no press release has been issued for this recall.

Heparin sodium injection is a prescription medication used to prevent blood clots during specific medical procedures and long hospital stays. It can also be used to treat certain blood vessel, heart, and lung conditions. Pharmacists should identify and quarantine Lot CU03232A, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. October 28, 2026. Accessed October 28, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=223195