CRITICALPharmacy / CompoundingFDA Warning Letter · September 9, 2025

MedClub by Dr. Jenn

Atlas ID: 2025-09-fda-medclub-by-dr-jenn-akure4

FDA issued a warning letter to MedClub by Dr. Jenn (Dr. Jenn Guthrie, MD) in West Palm Beach, FL, after reviewing the website drjennpb.com in June 2025 and finding it offered compounded retatrutide and semaglutide products. Compounded retatrutide was cited as an unapproved new drug and misbranded drug because retatrutide does not appear on the 503A or 503B bulks lists and is not a component of any FDA-approved drug. Compounded semaglutide products were cited as misbranded due to false or misleading claims including 'FDA Approved,' 'Generic Ozempic,' and 'USA Compounded'/'Custom Compounded,' which falsely implied equivalence to FDA-approved products. 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)

Custom Compounded

Other · false-equivalence-to-approved-drug

Generic Ozempic

Comparative claim w/o evidence · false-generic-equivalence

FDA Approved

FDA trademark misuse · fda-approved-misuse

USA Compounded

Other · false-equivalence-to-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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