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Class II · ModerateActive recall

Heparin Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot# CU03232A, Exp 1/31/2028
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byHepalink USA Inc.
Brand nameHEPARIN SODIUM
Generic nameHEPARIN SODIUM
Active ingredient(s)HEPARIN SODIUM
Distributed by / forHepalink USA Inc., Langhome, PA 19047-1885. Carton
NDC81952-111-06
Show the full FDA record
Full product labelHeparin 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
Recalling firmShenzhen Techdow Pharmaceutical Co., Ltd.
DistributionNationwide in the USA.
Quantity251,000 1 mL multidose vials
Recall initiated2026-10-01
Report date2026-10-28
Recall completed—
Recall numberD-0050-2027
ClassificationClass II
FDA statusOngoing
Origin on fileShenzhen China

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.