API RED LIST Who's out. Who's in.
WARNING LETTER · 29 OCT 2026IA 66-79FEI 3015495180 · Tianjin

Tianjin Healthcare Medical: said it would stop, refused the records

A Tianjin API maker shipping to US compounding pharmacies told FDA it would quit the US market instead of handing over records. FDA put its drugs on Import Alert 66-79 anyway.

What FDA found
  1. Import records showed several API shipments for US pharmacy compounding that named the firm as maker.
  2. Asked for records on 17 June 2026, it replied a week later that it would stop making the products for the US, and refused.
  3. FDA wrote back that its API was still in the US and within expiry. The firm refused again.
  4. FDA also told it to update its registration within 30 days if it really has stopped.
Timeline

How it got here

17 JUN 2026 FDA records request under section 704(a)(4)
24 JUN 2026 Firm says it will stop US production and refuses
25 JUN 2026 FDA repeats the request. Refused again
25 AUG 2026 All drugs placed on Import Alert 66-79
29 OCT 2026 Warning Letter

They're out. Someone else makes it.

Open the list on API-FDF

Sources