Heparin Sodium Injection recall (Shenzhen Techdow Pharmaceutical Co., Ltd.)
DrugClass IIOngoing
Summary: Shenzhen Techdow Pharmaceutical Co., Ltd. is recalling 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: Lack of Assurance of Sterility.
What is being 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
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA.
How to tell if yours is affected
Lot# CU03232A, Exp 1/31/2028
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0050-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | October 1, 2026 |
| Reported | October 28, 2026 |
| Company | Shenzhen Techdow Pharmaceutical Co., Ltd. |
| Company location | Shenzhen, China |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 251,000 1 mL multidose vials |
More recalls from Shenzhen Techdow Pharmaceutical Co., Ltd. · all drug recalls · recalls from October 2026