enforcement database
FDA Unapproved Drug Warning Letters
53 documented actions on record. Warning letters citing marketing of a drug without required FDA approval.
- Total actions
- 53
- Earliest on record
- April 17, 2026
- Most recent
- October 1, 2026
- Source
- openFDA (warning_letter)
Severity breakdown
- Critical53
Most recent unapproved drug warning letters (30 of 53 shown)
- The Platinum Healthcare LLC — Unapproved New Drugs (2026-10-01)
October 1, 2026·Critical
- Amazon.com, Inc. — Unapproved New Drugs (2026-10-01)
October 1, 2026·Critical
- OrganiCare, LLC / OrganiCare Nature’s Science, LLC — Unapproved New Drugs (2026-10-01)
October 1, 2026·Critical
- Bioactive Services USA, LLC / Herstat Inc. — Unapproved New Drugs (2026-10-01)
October 1, 2026·Critical
- Graceful Touch, LLC — Unapproved New Drugs (2026-10-01)
October 1, 2026·Critical
- RoyceDerm LLC — Unapproved New Drugs (2026-10-01)
October 1, 2026·Critical
- DesBio/Deseret Biologicals, Inc. — Unapproved New Drugs (2026-10-01)
October 1, 2026·Critical
- Terramed — Unapproved New Drugs (2026-10-01)
October 1, 2026·Critical
- Aidance Scientific, Inc. — Unapproved New Drugs (2026-10-01)
October 1, 2026·Critical
- Walmart, Inc. — Unapproved New Drugs (2026-10-01)
October 1, 2026·Critical
- Online Generic Medicine/www.onlinegenericmedicine.com — Unapproved New Drug/Misbranded (Internet Pharmacy) (2026-09-23)
September 23, 2026·Critical
- Celmade — Review of Website/Unapproved New Drug/Misbranded (2026-09-14)
September 14, 2026·Critical
- NexCell Scientific Inc — Unapproved New Drugs/Unlicensed Biological Product Violations (2026-09-11)
September 11, 2026·Critical
- Royal Peptides LLC — Unapproved New Drugs/Misbranded (2026-08-24)
August 24, 2026·Critical
- TXP Innovations LLC dba Tex Peptides — Unapproved New Drugs/Misbranded (2026-08-24)
August 24, 2026·Critical
- NuScience Peptides LLC — Unapproved New Drugs/Misbranded (2026-08-24)
August 24, 2026·Critical
- Peak Performance Peptides — Unapproved New Drugs/Misbranded (2026-08-24)
August 24, 2026·Critical
- Peptide Partners LLC — Unapproved New Drugs/Misbranded (2026-08-24)
August 24, 2026·Critical
- R3 Medical Companies — Unapproved New Drugs/Unlicensed Biological Product Violations (2026-08-14)
August 14, 2026·Critical
- VasoCorp, Inc. — Unapproved New Drugs/Misbranded (2026-07-09)
July 9, 2026·Critical
- 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
- Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.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
- 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
- Keta Med Lab / www.ketamedlab.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
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.