CRITICALPharmacy / CompoundingFDA Warning Letter · September 9, 2025

GenLabMeds

Atlas ID: 2025-09-fda-genlabmeds-3vxc6y

FDA issued a warning letter to GenLabMeds, a telehealth/online pharmacy, in September 2025 after reviewing its website and finding it was selling compounded retatrutide, semaglutide, and tirzepatide products in violation of the FDCA. Retatrutide is not on the 503A or 503B bulks lists and is not an FDA-approved drug component, making GenLabMeds' compounded retatrutide products unapproved new drugs and misbranded drugs. Additionally, website claims falsely implied that compounded products were equivalent to or the same as FDA-approved branded drugs (e.g., Mounjaro, Zepbound, Ozempic, Wegovy). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Flagged claims (4)

What does the treatment plan generally look like? The standard, FDA-approved dosing schedule for Retatrutide is: Month 1: 0.25 mg per week…

FDA trademark misuse · fda-approved-misuse

Compounded Retatrutide [--] Active Ingredient in Mounjaro and Zepbound

FDA trademark misuse · false-equivalence-approved-drug

Compounded Retatrutide [--] Active Ingredient in Ozempic and Wegovy

FDA trademark misuse · false-equivalence-approved-drug

Doctors frequently recommend Compounded Tirzepatide (Mounjaro/Zepbound) or Compounded Semaglutide (Wegovy, Ozempic), which are both GLP-1 agonists.

FDA trademark misuse · false-equivalence-approved-drug

Required actions (3)

You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product).

Claim removal

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

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

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