CLASS II ONGOING Drug recall · Reported 28 Oct 2026 · FDA Enforcement Report
Heparin Sodium Injection recalled by Shenzhen Techdow
Shenzhen Techdow Pharmaceutical is recalling Heparin Sodium Injection, USP, 5,000 USP Units/mL Multi dose vial x 25 vials per, distributed nationwide in the US. The recall was initiated on 1 Oct 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0050-2027
- FDA event ID
- 100049
- Recalling firm
- Shenzhen Techdow Pharmaceutical, Shenzhen
- Brand
- Heparin Sodium
- Manufacturer
- Hepalink USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Oct 2026
- FDA classified
- 16 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Blood Thinners
Timeline
| 1 Oct 2026 | Recall initiated by company | |
| 16 Oct 2026 | Classified by FDA | +15 days |
| 28 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot# CU03232A, Exp 1/31/2028
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Heparin recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) recalledHeparin Sodium In Sodium Chloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Heparin Sodium, 25,000 USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose | B. Braun Medical | Potency & Assay | Nationwide |
| Drug | CLASS II | Heparin Sodium Injection, USP, 20,000 USP units per mL recalledHeparin Sodium | Sagent Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Heparin Sodium, 25,000USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose | B. Braun Medical | Potency & Assay | Nationwide |
| Drug | CLASS II | Heparin/lido HCL/sodium Bicarb 100u/2mg/16.8mg/ML Syringe) recalled | Pharmacy Innovations | Sterility | Nationwide |