eDrugstore
FDA issued a warning letter to eDrugstore (Tempe, AZ) in September 2025 after reviewing its website and finding that marketing claims for compounded tirzepatide falsely implied the products were FDA-approved, in violation of FDCA sections 502(a) and 502(bb). Specific claims included labeling the active ingredient as 'FDA-Approved Active,' guaranteeing products are 'genuine, FDA-approved formulations,' and equating the compounded product with the brand-name drug Zepbound. FDA found these claims misbranded the products and directed eDrugstore to immediately cease using the offending language, with a written corrective response required within 15 working days, and warned that failure to comply could result in seizure or injunction.
Flagged claims (3)
Tirzepatide (Zepbound)….
FDA-Approved Active
eDrugstore guarantees that all Tirzepatide medications are genuine, FDA-approved formulations for maximum efficacy and safety.
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).
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.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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