enforcement database
FDA Unapproved Drug Warning Letters
33 documented actions on record. Warning letters citing marketing of a drug without required FDA approval.
- Total actions
- 33
- Earliest on record
- April 17, 2026
- Most recent
- June 23, 2026
- Source
- openFDA (warning_letter)
Severity breakdown
- Critical33
Most recent unapproved drug warning letters (30 of 33 shown)
- ketaminetroches.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Med Shop Inc / www.medshopinc.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Legit Ketamine Suppliers / www.legitketaminesuppliers.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Ket Plug / ketaminelab.org and buyketaminepowderonline.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Extra Medication / www.extramedication.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Buy Keta Online / www.buyketaonline.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Ketdaxandrugs / www.ketdaxandrugs.org — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Ketamine Troche Store / www.ketaminetrochestore.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Ketamine Store / www.ketaminestore.org — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Keta Med Lab / www.ketamedlab.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Ketacyn Pharmaceuticals / www.ketacynpharma.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- All Ketamine HCL / www.allketaminehcl.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- LyfeUnit / www.lyfeunit.com — Unapproved New Drugs/Misbranded (2026-06-23)
June 23, 2026·Critical
- Leading Edge Health Inc. — Unapproved New Drugs/Misbranded (2026-06-17)
June 17, 2026·Critical
- MantroForce — Unapproved New Drugs/Misbranded (2026-06-17)
June 17, 2026·Critical
- Great India Overseas Pvt. Ltd. dba Silkrute — Unapproved New Drugs (2026-06-17)
June 17, 2026·Critical
- Wild Arabic Herbs — Unapproved New Drugs/Misbranded (2026-06-17)
June 17, 2026·Critical
- JJLBRO — Unapproved New Drugs/Misbranded (2026-06-17)
June 17, 2026·Critical
- Texinkart Inc. — Unapproved New Drugs/Misbranded (2026-06-17)
June 17, 2026·Critical
- Telos Trading Limited dba Alwinshop — Unapproved New Drugs/Misbranded (2026-06-17)
June 17, 2026·Critical
- Herbal Dermals LLC FZ dba Gotucream — Unapproved New Drugs/Misbranded (2026-06-17)
June 17, 2026·Critical
- Hadassah Healing Oils Ltd — Unapproved New Drugs (2026-06-17)
June 17, 2026·Critical
- Amazon.com, Inc. — Unapproved New Drugs/Misbranded (2026-06-17)
June 17, 2026·Critical
- Wholesale Peptide — Unapproved New Drugs/Misbranded (2026-06-17)
June 17, 2026·Critical
- Indiangoods.shop — Unapproved New Drugs/Misbranded (2026-06-17)
June 17, 2026·Critical
- Mineral BioSciences, LLC — Unapproved New Drugs/Misbranded (2026-06-05)
June 5, 2026·Critical
- Blue Horizon International, LLC — Unapproved New Drugs/Unlicensed Biological Product Violations (2026-05-26)
May 26, 2026·Critical
- Lus Essentials LLC — Unapproved New Drugs/Misbranded (2026-05-14)
May 14, 2026·Critical
- La Crema De Rebeca — Unapproved New Drugs/Misbranded (2026-05-14)
May 14, 2026·Critical
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.