• •FDA approved a higher dose semaglutide on March 19, 2026 under the CNPV program
• •CNPV targets 1-2 month review times vs. 6+ months for standard priority review
• •FDA held a public hearing on June 4, 2026 to gather feedback on the CNPV pilot

The FDA warned NativeMed, a Miami-based compounding pharmacy, for making false claims about its weight-loss drugs semaglutide and tirzepatide. The agency said NativeMed's website falsely suggested the compounded versions were FDA-approved and implied NativeMed made the drugs when it did not.

• •FDA reviewed NativeMed's website in March 2026 and issued warning letter on June 8, 2026
• •NativeMed's logo appeared on tirzepatide product labels, falsely implying it was the compounder
• •Website claimed compounded semaglutide contained 'The same active ingredient in Ozempic® and Wegovy®'

The FDA warned Eden Health International for making false claims about its compounded semaglutide and tirzepatide drugs. The company falsely labeled itself as the maker of the drugs and claimed its suppliers were "FDA-licensed," which doesn't exist—the FDA does not formally license compounding pharmacies.

• •FDA issued warning letter to Eden Health International (Denver, CO) on June 8, 2026
• •Eden labeled itself as compounder of semaglutide and tirzepatide products when it is not
• •Eden falsely claimed suppliers were 'FDA-licensed 503(a) outsourcing facilities' — no such designation exists

The FDA sent Altru Telehealth a warning letter for making false claims about compounded semaglutide and tirzepatide drugs on its website. The company claimed the drugs were FDA-approved and that compounding pharmacies were FDA-licensed, which is illegal — compounded drugs are not FDA-approved, and pharmacies don't receive FDA licenses.

• •FDA sent Altru Telehealth a warning letter dated June 8, 2026 (ref MARCS-CMS 728274)
• •Altru claimed compounded semaglutide 'offers the same results but at a fraction of the cost of brand names such as Ozempic, Mounjaro & Wegovy'
• •Altru must respond in writing within 15 business days or face seizure and injunction

The FDA warned AM RX, an online pharmacy, for making false claims about its compounded semaglutide and tirzepatide products. The company falsely suggested its products were FDA-approved and implied it made the drugs when it didn't.

• •FDA issued warning letter to FitRX LLC dba AM RX on June 8, 2026 (ref MARCS-CMS 728275)
• •AM RX labeled products as 'AM Rx' despite not being the actual compounder of the drugs
• •Website claimed semaglutide was 'the active ingredient in FDA-approved medications' — compounded drugs are not FDA-approved

The FDA warned Harper Meds, an online pharmacy, for making false claims about compounded semaglutide and tirzepatide drugs on its website. The agency said Harper Meds falsely claimed the drugs were FDA-approved and came from FDA-licensed facilities, which is illegal.

• •FDA issued warning letter MARCS-CMS 728281 to Harper Meds on June 8, 2026
• •Harper Meds falsely claimed compounded semaglutide had 'Same active ingredient as Ozempic & Wegovy'
• •Site falsely stated products came from 'FDA-licensed 503A Outsourcing Facilities' — no such designation exists

The FDA told D&H Medical Services to stop making false claims about its compounded weight-loss drugs semaglutide and tirzepatide. The company claimed its copies were the "same ingredient" as the brand-name drugs Ozempic, Rybelsus, and Mounjaro, but compounded drugs are not FDA-approved and cannot make those claims.

• •FDA issued warning letter MARCS-CMS 728238 to D&H Medical Services on June 8, 2026
• •D&H claimed compounded semaglutide/tirzepatide were 'Same ingredient as Ozempic®', 'Same ingredient as Mounjaro®'
• •FDA reviewed D&H's website in March 2026; company must respond within 15 business days

The FDA issued a warning letter to Amie Health for making false claims about compounded semaglutide and tirzepatide on its website. The company claimed these copies contain the same ingredients as brand-name drugs and used FDA-approved language, but compounded drugs are not FDA-approved.

• •FDA issued warning letter to Amie Health (Miami, FL) on June 8, 2026
• •Amie's site claimed Ozempic, Mounjaro, and Wegovy contain same active ingredients as its compounded versions
• •Amie claimed to use FDA-approved active ingredients; compounded drugs are not FDA-approved

The FDA warned Medica Weight Loss for making false claims about compounded semaglutide and tirzepatide on its website. The company falsely claimed the drugs were FDA-approved and sourced from an 'FDA-approved pharmacy'—neither statement is legal for compounded drugs.

• •FDA warned Medica Weight Loss (Aventura, FL) on June 8, 2026 for false claims about compounded semaglutide and tirzepatide
• •Website falsely claimed compounded drugs were 'FDA-approved' and sourced from an 'FDA-approved pharmacy'
• •Medica must respond in writing within 15 business days or face seizure and injunction

The FDA warned HydraMed, a Colorado pharmacy, for making false claims about its compounded semaglutide and tirzepatide products. The company falsely labeled itself as the maker of these drugs and claimed to be an FDA-approved pharmacy, which doesn't exist.

• •FDA issued warning letter to HydraMed IV LLC, Denver CO, dated June 8, 2026
• •HydraMed falsely labeled itself as maker of compounded semaglutide and tirzepatide products
• •HydraMed falsely claimed products came from an 'FDA-approved pharmacy,' a designation that does not exist

The FDA fined Nova Vascular (NOVARX), a compounding pharmacy, for making false claims about cheap copies of semaglutide and tirzepatide on its website. The company claimed its drugs were FDA-approved and sourced from FDA-approved pharmacies, which is illegal — compounded drugs are not FDA-approved, and pharmacies don't get FDA licenses.

• •FDA issued warning letter to Nova Vascular LLC dba NOVARX on June 8, 2026
• •NOVARX website claimed compounded drugs sourced from 'FDA Approved Pharmacies' — false per FDA
• •FDA reviewed NOVARX website at https://novarx.co in March 2026; FEI 3044022416

The FDA fined Momentum Health 360 for making false claims on its website about compounded weight-loss drugs like semaglutide and tirzepatide. The company falsely said its compounded drugs were FDA-approved and that it was a licensed compounder, when compounded drugs are not FDA-approved and pharmacies don't get FDA licenses.

• •FDA issued warning letter MARCS-CMS 728286 to Momentum Health 360 on June 8, 2026
• •Website falsely claimed compounded semaglutide and tirzepatide were from an 'FDA-licensed' facility
• •Violations found during FDA website review conducted in March 2026; company has 15 business days to respond

The FDA warned OrderlyMeds, a compounding pharmacy, that it made false claims about selling weight-loss drugs like semaglutide and tirzepatide. The company falsely said it was an FDA-licensed pharmacy and put its logo on drug labels it didn't actually make.

• •FDA issued warning letter MARCS-CMS 728291 to OrderlyMeds LLC, Decatur GA, on June 8, 2026
• •OrderlyMeds falsely claimed its compounded drugs came from an 'FDA-licensed pharmacy'
• •OrderlyMeds placed its own logo on drug labels for products it did not actually compound

The FDA warned Fitish, a compounding pharmacy, that it broke federal law by selling homemade versions of semaglutide and tirzepatide (weight-loss drugs) with false claims on its website. The company falsely suggested it made the drugs itself and implied they were FDA-approved, which is illegal for pharmacy-made copies.

• •FDA issued warning letter MARCS-CMS 728280 to Fitish, Fort Worth TX, dated June 8, 2026
• •Fitish website offered compounded semaglutide and tirzepatide with FITISH label, despite not being the compounder
• •FDA review was conducted in March 2026; Fitish has 15 business days to respond

The FDA warned Joi + Blokes, a Colorado company, for making false claims about compounded semaglutide and tirzepatide (copycat versions of Ozempic, Wegovy, and Mounjaro). The company's website falsely suggested these drugs were FDA-approved and that Joi + Blokes made them, when neither is true.

• •FDA issued warning letter MARCS-CMS 728283 to Joi + Blokes of Denver, CO on June 8, 2026
• •Joi + Blokes website falsely labeled products with its own name, implying it was the compounder when it was not
• •Website claimed compounded semaglutide was 'bioidentical with more expensive brands' like Ozempic and Wegovy

The FDA found that GLP-1 weight-loss drugs like Ozempic, Wegovy, and Mounjaro may cause intestinal blockages. The agency updated drug labels between late 2022 and mid-2023 to warn patients about this risk.

• •FDA updated GLP-1 drug labels between November 2022 and September 2023 to include ileus risk
• •Drugs affected include Mounjaro (tirzepatide), Ozempic, Wegovy, Rybelsus (all semaglutide), and others
• •The ileus warning was added to the 'Adverse Reactions' section of affected drug labeling

• •FDA flagged GLP-1 receptor agonists for non-arteritic anterior ischemic optic neuropathy (NAION)
• •Drugs named include Ozempic, Wegovy, Rybelsus, Mounjaro, and Zepbound
• •FDA is evaluating the need for regulatory action as of March 6, 2025

The FDA listed GLP-1 weight-loss drugs like Ozempic, Wegovy, Mounjaro, and Zepbound as having a possible safety signal for a nerve problem called dysaesthesia (abnormal skin sensations). The agency is still studying whether the drugs caused these reports and whether label changes are needed.

• •FDA identified dysaesthesia as a potential safety signal for the full GLP-1 receptor agonist drug class
• •Named drugs include Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, Victoza, Saxenda, Trulicity, Byetta
• •As of June 21, 2024, FDA is evaluating the need for regulatory action — no label changes made yet

The FDA warned patients and doctors about risks from unapproved weight-loss drugs like semaglutide and tirzepatide made by compounding pharmacies. The agency found problems with storage, fake products, wrong doses, and counterfeit versions that could harm patients.

• •As of July 31, 2025, FDA received 605 adverse event reports for compounded semaglutide
• •As of July 31, 2025, FDA received 545 adverse event reports for compounded tirzepatide
• •Retatrutide and cagrilintide cannot be used in compounding under federal law

Maryland's state drug board set a price cap on Ozempic (a weight-loss and diabetes drug made by Novo Nordisk). Nine states are trying similar rules to make expensive drugs cost less for patients.

• •Maryland state drug affordability board set a price cap on Ozempic
• •Nine states are pursuing similar drug price cap rules
• •Ozempic is made by Novo Nordisk