HEPARIN SODIUM
Recalling Firm / Manufacturer: Shenzhen Techdow Pharmaceutical Co., Ltd.
(Shenzhen, China)
FDA Recall Number: D-0050-2027
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
HEPARIN SODIUM
Generic Name
HEPARIN SODIUM
Active Substance(s)
Heparin Sodium
Administration Route
Intravenous
National Drug Code (NDC)
81952-111
Total Quantity Recalled
251,000 1 mL multidose vials
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Lack of Assurance of Sterility
Full Product Description
Packaging specifications and labeling details
Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome, PA 19047-1885. Carton NDC: NDC 81952-111-06, Vial NDC: 81942-111-01
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
October 28, 2026
Firm Initiation Date
October 01, 2026
FDA Classification Date
Oct 16, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot# CU03232A, Exp 1/31/2028
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA.
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0050-2027
Questo Retrieval Date: November 03, 2026 00:00 1793664007UTCC