CRITICALGLP-1 / Weight LossFDA Warning Letter · February 20, 2026

Kare Solutions, LLC dba Zappy

Atlas ID: 2026-02-fda-kare-solutions-llc-dba-zappy-1x3vec

FDA issued a warning letter to Kare Solutions, LLC dba Zappy (La Jolla, CA), a telehealth platform offering compounded semaglutide, tirzepatide, and liraglutide products, for misbranding violations under FDCA sections 502(a) and 502(bb). The website falsely displayed 'Zappy' on product labels implying it was the compounder, and made claims linking its compounded products to FDA-approved branded drugs (Wegovy®, Saxenda®, Zepbound®) and describing them as 'a proven medication' and 'clinically studied,' implying FDA approval that compounded drugs do not have. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Flagged claims (5)

Semaglutide (Active Pharmaceutical Ingredient in Wegovy®)See Wegovy FDA Information

FDA trademark misuse · fda-approved-misuse

Liraglutide (Active Pharmaceutical Ingredient in Saxenda®)See Saxenda FDA Information

FDA trademark misuse · fda-approved-misuse

Tirzepatide (Active Pharmaceutical Ingredient in Zepbound®)See Zepbound FDA Information

FDA trademark misuse · fda-approved-misuse

Clinically studied and shown to deliver powerful results when combined with healthy habits.

Unsubstantiated efficacy · implied-fda-approval

a proven medication

Unsubstantiated efficacy · implied-fda-approval

Required actions (5)

Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.

Response required · 15 days

Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].

Claim removal

Identifying the entities that produce the compounded products offered on your website;

Other

Providing a representative sample of labeling for such products;

Recordkeeping

Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

Does your site contain similar claims?

The free site audit scans your site against every entry in this Atlas. Most glp-1 / weight loss sites match 3-6 patterns.

Run my free site audit