Ivim Services LLC dba Ivim

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.

Violations3

Issue DateFeb 20, 2026

Product TypeDrugs

StatusOpen

Letter Details

Firm: Ivim Services LLC dba Ivim
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

Ivim Services LLC, which offers compounded semaglutide and tirzepatide products, was cited for misbranding violations under the Federal Food, Drug, and Cosmetic Act. The company's website falsely represented that Ivim was the compounder of these drugs when it was not, resulting in misleading labeling and advertising that violated sections 502(a) and 502(bb) of the FDCA. By promoting these misbranded products through interstate commerce, Ivim violated section 301(a) of the FDCA, which prohibits the introduction or delivery of such products into commerce.

Ivim Services LLC dba Ivim FDA Warning Letter, February 20, 2026