Nanjing Hanxin: blocked at the border since June
FDA put every drug from this Nanjing API maker on Import Alert 66-40 in June. The November letter says Hanxin's name on the paperwork may have covered for the real manufacturer, a supplier FDA had already blocked.
Is your product on this list?
Products at risk. Who's in.
DMF on fileAPI, supply not confirmed
| MOLECULE | FORM | SOLD IN THE US BY | LINK TO SITE | RISK | WHO'S IN | Action |
|---|---|---|---|---|---|---|
| Tirzepatide | API (peptide) | Not disclosed by FDA | DMF ON FILE | IMPORT ALERT | 23 API (15 US DMF) | See who's in |
FDA often redacts product names in its letters. Rows marked "FDA label" come from openFDA drug labels that name this site. "Who's in" counts manufacturers of the same molecule in the API-FDF database; names and contacts are inside.
What FDA found
- The quality unit did not qualify suppliers of critical raw materials for an API sold to the US.
- The supplier of a critical starting material makes drugs that FDA placed on Import Alert 66-40.
- FDA says naming Hanxin instead of the actual manufacturer may have been an attempt to get around safeguards.
- Hanxin told FDA that after November 2025 production of that API moved to a subsidiary.
Timeline
How it got here
18 NOV 2025
FDA requests records under section 704(a)(4)
22 JUN 2026
All Hanxin drugs placed on Import Alert 66-40
3 NOV 2026
Warning Letter