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FDA classifies Techdow heparin sodium injection recall as Class II over sterility assurance

🇺🇸 FDA enforcement report · Wed 28 Oct 2026

Shenzhen Techdow Pharmaceutical's heparin sodium injection recall, numbered D-0050-2027, is listed as ongoing and covers nationwide distribution in the US.

The US Food and Drug Administration has listed a Class II recall of Heparin Sodium Injection from Shenzhen Techdow Pharmaceutical Co., Ltd. in its enforcement report dated 28 October 2026. The recall carries the number D-0050-2027.

The stated reason is a lack of assurance of sterility. The enforcement entry shows the recall as ongoing, and the product was distributed nationwide in the United States.

The text available to VigiEye consists mainly of the enforcement report's search-page interface and does not include the product-level record. It therefore gives no details on lot numbers, expiry dates, strengths, quantities, the date the recall began or the underlying cause of the sterility concern. Those details should be checked in the full FDA database entry.

For context, the FDA applies a Class II designation to recalls where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Hospital pharmacy, wholesaler and quality teams handling US heparin supply should check the full FDA entry for D-0050-2027 to identify affected lots and presentations.
  • Pharmacovigilance teams may wish to review any complaints or adverse event reports on heparin injections that could relate to sterility, using batch information from the full record.
  • Because the recall is ongoing and nationwide, supply-continuity planning should allow for further updates from the FDA or the recalling firm.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

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