Aspen Aesthetics dba Fifty 410

Warning LetterOpen

United StatesIssued Feb 20, 2026Center for Drug Evaluation and Research (CDER)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations2

Issue DateFeb 20, 2026

Product TypeDrugs

StatusOpen

Letter Details

Firm: Aspen Aesthetics dba Fifty 410
Location: United States
FEI Number: N/A
Country: United States
Issue Date: February 20, 2026
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Aspen Aesthetics dba Fifty 410 was cited for misbranding compounded semaglutide and tirzepatide products sold through their website. The company falsely represented that Fifty 410 was the compounder of these drugs when it was not, and made unsupported claims that the products contained "clinically proven ingredients," implying FDA approval or safety evaluation that had not occurred. These violations of sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act resulted in misbranded drugs being introduced into interstate commerce without proper authorization or substantiation.

Aspen Aesthetics dba Fifty 410 FDA Warning Letter, February 20, 2026