The Red List
FDA Warning Letters, Import Alerts, EU non-compliance reports and suspended CEPs that take supply off the US and EU markets, with the number of alternative manufacturers in the API-FDF database.
| DATE | SITE | STATUS | WHAT STOPS | WHO'S IN |
|---|---|---|---|---|
| 03 NOV 2026 | Nanjing Hanxin, China | WARNING LETTERIA 66-40 | APIs for sterile products and compounding | Tirzepatide23 API (15 US DMF) |
| 02 NOV 2026 | USV, Daman, India | WARNING LETTERSTERILE LINE STOPPED FOR US | Sterile line (octreotide inj.), oral generics | Octreotide acetate14 API (12 US DMF) · 25 FDF |
| 29 OCT 2026 | Chongqing Qiancan, China | WARNING LETTERIA 66-79 | APIs shipped for US compounding | Products not named by FDA |
| 29 OCT 2026 | Tianjin Healthcare Medical, China | WARNING LETTERIA 66-79 | APIs shipped for US pharmacy compounding | Products not named by FDA |
| 16 OCT 2026 | Glukem Biocare, India | EU NCR | Drug pellets (intermediates) for EU medicines | Products not named in the NCR |
| 29 SEP 2026 | Baxter, Round Lake, USA | WARNING LETTERRECALL | Premixed IV bags (Galaxy) from a shared beta-lactam building | Vancomycin17 API (12 US DMF) · 38 FDF |
| 28 SEP 2026 | OCB Pharmaceutical, Spain | EU NCRCEP SUSPENDED | All APIs from the site: nine bismuth salts | Bismuth subsalicylate7 API (0 CEP) |
| 21 SEP 2026 | Xi'an Guokang Ruijin, China | EU NCRCEP SUSPENDED | Dexamethasone and betamethasone APIs for the EU | Dexamethasone31 API (5 CEP) |
| 19 SEP 2026 | Chengdu Shengnuo, China | IMPORT ALERT 66-40 | Peptide APIs: lanreotide, ganirelix, linaclotide | Lanreotide acetate8 API (5 US DMF) |
| 24 AUG 2026 | Aculife Healthcare, India | EU NCR | Sterile IV bags and eye drops filed in the EU | Sodium chloride 0.9%12 FDF |
| 21 AUG 2026 | Lianyungang Guike, China | EU NCRCEP SUSPENDED | Neuromuscular blocker APIs for the EU | Atracurium besilate11 API (4 CEP) |
| 12 AUG 2026 | Uquifa Mexico, Mexico | CEP SUSPENDED | Ten generic APIs for the EU | Venlafaxine hydrochloride63 API (21 CEP) |