FDA recall, , Moderate risk
Shenzhen Techdow Pharmaceutical Heparin Sodium Injection
Heparin Sodium Injection lacks assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Shenzhen Techdow Pharmaceutical Co., Ltd. recalled Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, distributed by Hepalink USA Inc., due to lack of assurance of sterility. The recall was initiated on October 1, 2026, and added to the FDA's Enforcement Report on October 16, 2026. The product was distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 81952-111-06
- 81942-111-01
- Lot code
- CU03232A
Recall details
- Company began the recall
- Sold in
Nationwide in the USA.
- Company
- Shenzhen Techdow Pharmaceutical Co., Ltd.
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 100049
- Recall number
- D-0050-2027
- Quantity recalled
- 251,000 1 mL multidose vials
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
