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

FDA recall notice · announced October 28, 2026 · Shenzhen Techdow Pharmaceutical Co

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

Lack of Assurance of Sterility

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot# CU03232A, Exp 1/31/2028
Quantity: 251,000 1 mL multidose vials
Status: Ongoing
Products in this recall event:
- 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- (D-0050-2027)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.