GLP-1 / Weight Loss

Harbin Jixianglong Biotech Co., Ltd.

FDA issued a warning letter to Harbin Jixianglong Biotech Co., Ltd., a Chinese manufacturer of peptide APIs including semaglutide and tirzepatide, following a November 2025 inspection. The agency found the firm purchased semaglutide API from unapproved suppliers, repackaged and relabeled it under its own name with falsified manufacturing and retest dates, and distributed it to the U.S. market — conduct FDA characterized as potentially circumventing Import Alert 66-80 safeguards. Additional violations included lack of process and cleaning validation, inadequate analytical method validation, insufficient water quality controls, and drug listing/misbranding violations. The firm was placed on Import Alert 66-40 (detention without physical examination), removed from the GLP-1 Green List, and initiated a voluntary recall of two semaglutide API batches.

New Life Pharma LLC

FDA issued a warning letter to New Life Pharma LLC (Northvale, NJ) after a February 2026 inspection found the company was manufacturing and distributing unapproved semaglutide and tirzepatide sterile multi-dose vials — GLP-1 drugs shipped primarily to weight loss clinics and med spas — without FDA approval, proper registration, or adequate sterility controls. The products were deemed unapproved new drugs, misbranded, and adulterated due to pervasive CGMP failures including no aseptic process validation, no environmental monitoring, and no sterility testing. The company also denied FDA investigators access to portions of its manufacturing suite, further adulterating the drugs under FD&C Act section 501(j). A voluntary recall of all distributed batches was issued on February 25, 2026, and FDA demanded the firm confirm it will permanently cease drug manufacturing.

ProRx LLC

ProRx LLC, a 503B outsourcing facility in Exton, PA, received an FDA Warning Letter following a September 2025 inspection that found the company compounding tirzepatide and semaglutide injectable products under insanitary conditions with serious sterility assurance failures. The facility violated section 503B by using tirzepatide bulk drug substance not on the 503B bulks list, omitting required label statements, and failing to maintain adequate adverse event reporting procedures. Multiple CGMP violations were cited including inadequate contamination investigations, blocked first air during aseptic operations, and use of non-sterilized equipment in ISO 5 areas. FDA demanded a written response within 15 working days and warned that failure to correct violations may result in seizure or injunction.

Prime Sciences

FDA issued a warning letter to Prime Sciences (Scottsdale, AZ) on March 31, 2026, after reviewing their website and finding that they were selling unapproved new drugs — including Cagrilintide, Retatrutide, Semaglutide, Tirzepatide, Mazdutide, and BAC water — in violation of sections 301(d) and 505(a) of the FD&C Act. Despite labeling the products as 'for laboratory research purposes only,' the website's marketing copy made clear the products were intended for human use in weight loss and diabetes management. FDA warned that failure to correct these violations could result in seizure and injunction, and required a written response within fifteen working days.

Guangzhou Huli Technology Co., Ltd. dba Fantasy Face

FDA issued a warning letter to Guangzhou Huli Technology Co., Ltd. dba Fantasy Face (operating an eBay store) for selling 'Googeer GLP-1 Weight Control Oral Solution' in the United States without an approved new drug application. The product's labeling made drug-intended-use claims including weight management, blood sugar balance, and body shaping, qualifying it as an unapproved new drug under FD&C Act sections 301(d) and 505(a). FDA requires written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

PekCura Labs

FDA issued a warning letter to PekCura Labs (Jonathan Snider and Jonathan Speck, Pensacola, FL) on March 31, 2026, after reviewing their website in January 2026. The agency found that PekCura Labs was selling injectable peptide products marketed as 'GLP-1-S,' 'GLP-2-T,' 'GLP-3-R,' and 'Bacteriostatic Water' — all unapproved new drugs under section 505(a) of the FD&C Act — with product pages making explicit disease-treatment and body-weight-reduction claims referencing clinical studies. Despite 'research use only' disclaimers, FDA determined the products were intended for human use based on the marketing language, and warned that failure to correct violations could result in seizure and injunction.

Mile High Compounds LLC

FDA issued a warning letter to Mile High Compounds LLC (Clifton, CO) on March 31, 2026, after reviewing the company's website and affiliated community forum from January to March 2026. The company was found to be selling unapproved new drugs — including products containing semaglutide ('GLP-1 SM'), tirzepatide ('GLP-2 TRZ'), retatrutide ('GLP-3 RT'), and bacteriostatic water ('BAC Water') — marketed under research-only labels but with clear human-use dosing and therapeutic claims. FDA determined these products are intended for human use to treat obesity and metabolic conditions, making them unapproved new drugs in violation of sections 301(d) and 505(a) of the FD&C Act. The company was directed to respond within 15 working days, with failure to comply potentially resulting in seizure and injunction.

Gram Peptides

FDA issued a warning letter to Gram Peptides (Bernard Gramlich, Rancho Santa Fe, CA) on March 31, 2026, after reviewing the company's website and finding it offered Retatrutide, Tirzepatide, and Bacteriostatic Water for Injection for sale as unapproved new drugs. Despite 'Research Use Only' disclaimers, the website's marketing claims—describing appetite suppression, weight loss, glucose regulation, and metabolic benefits—established intended human drug use under the FD&C Act. FDA cited violations of sections 301(d) and 505(a) of the FD&C Act and warned that failure to correct may result in seizure or injunction.

Lovega LLC dba Pink Pony Peptides

FDA issued a warning letter to Lovega LLC dba Pink Pony Peptides (Susan Vega, Wellington, FL) after reviewing the company's website in December 2025 and finding that three products — 'GLP-2 TZ' (tirzepatide), 'GLP-3 RT' (retatrutide), and 'Bacteriostatic Water' — were being sold as unapproved new drugs in violation of sections 301(d) and 505(a) of the FD&C Act. Despite 'research purposes only' disclaimers, the website's marketing copy made explicit human-use drug claims including appetite suppression, fat loss, insulin sensitivity, and glucose control. FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within fifteen working days.

Novo Nordisk Inc.

FDA issued a Warning Letter to Novo Nordisk Inc. (NNI) following a January–February 2025 inspection that revealed serious violations of postmarketing adverse drug experience (PADE) reporting regulations under 21 CFR 314.80, affecting products including semaglutide and liraglutide. NNI failed to develop adequate written procedures ensuring timely 15-day Alert reporting of serious and unexpected ADEs, improperly rejected reportable cases based on reporter-assessed causality, and failed to promptly investigate ADEs subject to expedited reporting. FDA found systemic failures in NNI's pharmacovigilance program—including inadequate vendor oversight and corrective actions—and requires a written response within 15 business days detailing remediation steps, with the warning that failure to adequately address these issues may lead to further regulatory action.

Strut Health, LLC dba Strut

FDA issued a warning letter to Strut Health, LLC dba Strut (CEO Simal Patel, MD) on February 20, 2026, concerning false or misleading claims on its website regarding compounded semaglutide and tirzepatide products. The agency found that Strut's website falsely implied the company itself was the compounder of these drugs (by displaying 'Strut' on product labels) and that claims such as 'Generic Zepbound, Mounjaro' falsely implied FDA approval or evaluation for safety and effectiveness. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Premium Health Management Inc. dba Premium Health

FDA issued a warning letter to Premium Health Management Inc. dba Premium Health (Santa Ana, CA) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The FDA found that the website falsely implied Premium Health was the compounder of the products and that the products had received FDA approval or evaluation for safety and effectiveness. The products were deemed misbranded under FDCA sections 502(a) and 502(bb), with their interstate commerce constituting a prohibited act under section 301(a). The company was given 15 working days to respond with corrective steps, and was warned that failure to comply may result in seizure or injunction.

Weightless Medical LLC dba WeightCare

FDA issued a warning letter to Weightless Medical LLC dba WeightCare on February 20, 2026, after reviewing the company's website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with labels identifying 'WeightCare' as the compounder when it is not. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the introduction of these misbranded products into interstate commerce violates section 301(a). FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Aspen Aesthetics dba Fifty 410

FDA issued a warning letter to Aspen Aesthetics dba Fifty 410 (Prosper, TX) on February 20, 2026, concerning its website marketing of compounded semaglutide and tirzepatide products. The agency found two categories of misbranding violations: (1) the product labels displayed on the website identified 'Fifty 410' as the compounder when it is not, constituting a false or misleading representation under FDCA §§ 502(a) and 502(bb); and (2) the claim 'clinically proven ingredients' falsely implied FDA approval or evaluation for safety and effectiveness for unapproved compounded drugs. FDA demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Join Josie

FDA issued a warning letter to Join Josie, a website offering compounded semaglutide and tirzepatide products, for misbranding violations under FDCA sections 502(a) and 502(bb). The site falsely displayed the 'Join Josie' label on compounded drug products, implying the company was the compounder when it was not, and made misleading claims linking its compounded products to FDA-approved brands Wegovy® and Zepbound®, implying FDA approval or evaluation that does not exist. FDA found these representations false or misleading, constituting misbranding and prohibited interstate commerce under section 301(a). Join Josie was directed to respond within 15 working days with corrective steps, and warned that failure to comply may result in seizure or injunction.

Kare Solutions, LLC dba Zappy

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.

Better Health Labs, Inc. dba Measured

FDA issued a warning letter to Better Health Labs, Inc. dba Measured (New York, NY) on February 20, 2026, after reviewing the company's website trymeasured.com in December 2025. The agency found that Measured's website falsely implied the company itself was the compounder of semaglutide and tirzepatide products by displaying the 'Measured' brand name on product labels, and that marketing claims comparing compounded products to FDA-approved drugs (Wegovy, Ozempic, Zepbound, Mounjaro) falsely implied FDA approval or evaluation for safety and effectiveness. These representations rendered the products misbranded under FDCA sections 502(a) and 502(bb), and FDA warned that failure to adequately address violations may result in seizure and injunction.

MaxLife Technologies Inc. dba Maxlife

FDA issued a warning letter to MaxLife Technologies Inc. dba Maxlife (Irvine, CA) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The company falsely labeled products with the 'Maxlife' brand as if it were the compounder, and made multiple claims that the compounded drugs were 'FDA-approved' or equivalent to FDA-approved branded products, when compounded drugs are not FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.

Levity Inc. dba Levity

FDA issued a warning letter to Levity Inc. dba Levity (Delray Beach, FL) on February 20, 2026, after reviewing their website in December 2025 and finding that compounded semaglutide and liraglutide products were marketed with false or misleading claims. The company's website displayed the 'Levity' brand name on product labels despite Levity not being the actual compounder, and used claims implying FDA approval by referencing brand-name drugs Ozempic, Wegovy, and Saxenda. FDA found these practices constitute misbranding under FDCA sections 502(a) and 502(bb), with interstate commerce violations under section 301(a), and warned that failure to respond could result in seizure or injunction.

PharmaZee

FDA issued a warning letter to PharmaZee (Las Vegas, NV) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely identified PharmaZee as the compounder of the drugs and made claims implying FDA approval or clinical validation for unapproved compounded products. FDA cited misbranding violations under FDCA sections 502(a) and 502(bb) and demanded a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Genesis Health International Inc. dba Genesis

FDA issued a warning letter to Genesis Health International Inc. dba Genesis (Boynton Beach, FL) on February 20, 2026, after reviewing their website trygenesis.com in December 2025. The agency found that Genesis falsely represented itself as the compounder of semaglutide and tirzepatide products by displaying the 'Genesis' name on product labels, and made misleading claims implying FDA approval by stating their products contain 'the same active ingredient as Ozempic® and Wegovy®' and 'Same active ingredient as Mounjaro®.' These practices rendered the products misbranded under FDCA sections 502(a) and 502(bb), and FDA warned that failure to address violations may result in seizure and injunction.

FitRX, LLC dba FitRx

FDA issued a warning letter to FitRX, LLC dba FitRx (New York, NY) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The letter cites two categories of violations: (1) the FitRx label appearing on product images implies FitRx is the compounder when it is not, and (2) website claims linking their compounded products to FDA-approved brand-name drugs (Wegovy, Ozempic, Zepbound, Mounjaro) falsely imply FDA approval or evaluation for safety and effectiveness. Both violations constitute misbranding under FDCA sections 502(a) and 502(bb), and FitRx was given 15 working days to respond with corrective steps or face potential seizure and injunction.

Good Girl LLC dba GoodGirlRX

FDA issued a warning letter to Good Girl LLC dba GoodGirlRX (CEO Savannah Chrisley) in February 2026 after reviewing the company's website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely labeled products as if GoodGirlRX were the compounder, and made claims that compounded drugs were 'FDA-approved' or 'clinically proven,' when compounded drugs are not FDA-approved. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), and warned that failure to address violations may result in seizure or injunction.

Lean Rx, Inc. dba SkinnyRx

FDA issued a warning letter to Lean Rx, Inc. dba SkinnyRx (Sacramento, CA) on February 20, 2026, after reviewing the company's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The letter cites two categories of violations: (1) the website's product images display the 'SkinnyRx' label, falsely implying SkinnyRx is the compounder of the drugs, and (2) marketing claims imply FDA approval or equivalence to FDA-approved medications, which is false for compounded products. FDA found these practices constitute misbranding under FDCA sections 502(a) and 502(bb) and demanded a written corrective response within 15 working days, warning that failure to comply may result in seizure or injunction.

Zeuss LLC dba Zeuss

FDA issued a warning letter to Zeuss LLC dba Zeuss on February 20, 2026, regarding its website marketing of compounded tirzepatide products. The agency found the products misbranded under FDCA sections 502(a) and 502(bb) because the website falsely implied Zeuss was the compounder of the drugs, and made claims suggesting the compounded products were FDA-approved or clinically proven when they are not. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics

FDA issued a warning letter to Deluxe IV Aesthetics PLLC dba Deluxe IV and Aesthetics (Las Vegas, NV) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The company's website falsely implied it was the compounder of these drugs by displaying its name on product labels, and made claims linking its compounded products to FDA-approved brand-name drugs (Ozempic®, Mounjaro®, Wegovy®, Rybelsus®, Zepbound®), thereby misleadingly implying FDA approval or evaluation for safety and effectiveness. FDA found the products misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited acts under section 301(a). The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

BluefitMD

FDA issued a warning letter to BluefitMD (Lakewood Ranch, FL) on February 20, 2026, after reviewing their website in December 2025 and finding false or misleading claims about compounded semaglutide and tirzepatide products. The website falsely identified BluefitMD as the compounder of these drugs when it was not, and marketing language implied the compounded products shared FDA-approved status with brand-name drugs like Ozempic®, Wegovy®, Mounjaro®, and Zepbound®. FDA determined the products were misbranded under FDCA sections 502(a) and 502(bb), constituting prohibited interstate commerce under section 301(a). BluefitMD was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

Bliv Wellness LLC dba Bliv

FDA issued a warning letter to Bliv Wellness LLC dba Bliv (Ogden, UT) on February 20, 2026, after reviewing the company's website in December 2025 and finding that it offered compounded semaglutide and tirzepatide products with the 'Bliv' name on the pictured product labels, falsely implying Bliv is the compounder of those drugs when it is not. This constitutes misbranding under FDCA sections 502(a) and 502(bb), and the introduction of these misbranded products into interstate commerce violates section 301(a). FDA required a written response within 15 working days describing corrective steps, and warned that failure to adequately address violations may result in seizure or injunction.

Thrive Health and Wellness, LLC dba Thrive Health Solutions

Thrive Health and Wellness, LLC dba Thrive Health Solutions (Englewood, CO), owned by Doug Hatch, received an FDA Warning Letter following a March–April 2025 inspection that found serious sterility deficiencies in the repackaging of drug products including NAD+ 50 mg/mL and MEGALean (Tirzepatide/Cyanocobalamin) Injections. The firm conducted aseptic operations outside certified ISO 5 areas, used non-sterile gloves and wipes, had carpeted flooring in processing areas, and never performed media fills, rendering products adulterated under FDCA section 501(a)(2)(A). The products were also cited as unapproved new drugs and misbranded under FDCA sections 505(a) and 502(f)(1); the firm voluntarily ceased repackaging and initiated a recall of all affected products dispensed between January 2 and April 18, 2025. FDA warned that failure to adequately address violations may result in seizure and injunction.

NextMed

NextMed (Southern Health Solutions, Inc.), a telemedicine company offering weight-loss membership programs, was charged by the FTC with using deceptive claims about costs and weight-loss outcomes, fake reviews, and fake testimonials to attract consumers. The company also concealed material terms and conditions of its membership programs. Under the proposed consent order, NextMed and its principals agreed to pay $150,000, which is expected to be used to provide refunds to affected consumers.

Apothecary Pharma, LLC

FDA issued a warning letter to Apothecary Pharma, LLC (Cary, NC), a 503B outsourcing facility, following a May 2025 inspection that revealed serious sterile manufacturing deficiencies and failure to meet 503B conditions. The facility compounded GLP-1 products including Tirzepatide Injection 10 mg/mL and Semaglutide Injection 2.5 mg/mL with inadequate labeling, deficient adverse event reporting procedures, and multiple insanitary aseptic processing practices that rendered drug products adulterated and misbranded. Because the 503B conditions were not met, the compounded drugs are also unapproved new drugs subject to FDA approval requirements. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Ralph A. DeFronzo, M.D.

FDA issued a warning letter to Dr. Ralph A. DeFronzo, a clinical investigator at the University of Texas Health Science Center in San Antonio, following a December 2024 inspection of two clinical investigations involving investigational drugs, one of which involved GLP-1 receptor agonist-related eligibility criteria. The letter cites two primary violations: (1) failure to ensure subjects met protocol eligibility criteria before enrollment — all seven enrolled subjects had disqualifying blood pressure readings, eGFR values, or were on excluded medications (SGLT2 inhibitors and GLP-1 receptor agonists) — and (2) failure to promptly report a material change in study design (from a double-blind placebo-controlled trial to a pilot feasibility study) to the IRB before enrolling and treating all seven subjects. FDA found Dr. DeFronzo's corrective responses inadequate and required a written response within 15 business days detailing actions taken to prevent future violations, warning that failure to adequately respond may lead to regulatory action.

Chengdu Brilliant Biopharmaceutical Co., Ltd.

FDA issued a warning letter to Chengdu Brilliant Biopharmaceutical Co., Ltd., a Chinese API manufacturer, for significant CGMP deviations related to its Semaglutide (GLP-1 receptor agonist) API. The agency found the firm failed to conduct process validation for Semaglutide and failed to perform identity testing on incoming raw materials used in API manufacturing. FDA placed all drugs from this facility on Import Alert 66-40 as of July 9, 2025, and warned that continued non-compliance could result in refused admission of articles into the United States under the FD&C Act.

AnuMed International, LLC

AnuMed International, LLC, a Phoenix-based drug manufacturer, received an FDA Warning Letter on August 20, 2024, citing multiple unapproved new drugs sold without FDA approval, including a 'Semaglutide Homeopathic Formula,' bio-identical hormone creams, and various supplement products making disease treatment claims. The company's products were also found to be misbranded—falsely implying FDA approval by labeling products as made in an 'FDA Approved Facility' or 'FDA registered facility'—and adulterated due to serious CGMP violations including failure to perform identity testing on components such as glycerin and ethanol. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.