On October 1, 2026, Shenzhen Techdow Pharmaceutical Co., Ltd. initiated a recall of Heparin Sodium Injection, USP, due to a lack of assurance of sterility. The recall, classified as Class II, may cause temporary or reversible health problems and affects products distributed nationwide in the USA.
The recall involves 5,000 USP Units/mL, 1mL multi-dose vials, with carton NDC 81952-111-06 and vial NDC 81942-111-01, according to the Food and Drug Administration.
Press Release: Food and Drug Administration
Published October 28, 2026. Reproduced in full from the Food and Drug Administration.
Shenzhen Techdow Pharmaceutical Co., Ltd. drug recall
- Recalling company: Shenzhen Techdow Pharmaceutical Co., Ltd.
- Classification: Class II (may cause temporary or reversible health problems)
- Recall numbers: D-0050-2027
- Status: Ongoing
- Distribution: Nationwide in the USA.
- Recall started: October 1, 2026
What was recalled
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
Why
Lack of Assurance of Sterility
This drug recall appears in the FDA's weekly enforcement report. Details: FDA recall event 100049.