Heparin Sodium Injection, Solution
FDA Recall NDC 81952-116
Latest: Class II · Status: Ongoing · Initiated Oct 01, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Heparin Sodium (NDC 81952-116). A significant event, classified as Class II, was initiated on Oct 01, 2026 by Hepalink Usa Inc.. The reported reason for this action was: "Lack of Assurance of Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility
Oct 01, 2026
Oct 28, 2026
251,000 1 mL multidose vials
Recall Profile & Regulatory Data
Event ID
100049
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Shenzhen Techdow Pharmaceutical Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
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
Batch or Lot Expiration Information
Lot# CU03232A, Exp 1/31/2028
Affected Packages Involved in this Recall
81952-113-01Heparin Sodium
81952-113-06Heparin Sodium
81952-113-03Heparin Sodium
81952-113-08Heparin Sodium
81952-116-01Heparin Sodium
81952-116-06Heparin Sodium
81952-112-01Heparin Sodium
81952-112-06Heparin Sodium
81952-112-04Heparin Sodium
81952-112-09Heparin Sodium
81952-112-05Heparin Sodium
81952-112-10Heparin Sodium
81952-111-01Heparin Sodium
81952-111-06Heparin Sodium
81952-115-02Heparin Sodium
81952-115-07Heparin Sodium
81952-114-04Heparin Sodium
81952-114-09Heparin Sodium
81942-111-01Heparin Sodium
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
