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 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 proposed removing semaglutide, tirzepatide, and liraglutide from the list of bulk substances that compounding pharmacies can use to make cheaper copies of these weight-loss and diabetes drugs. If approved, patients would no longer be able to get compounded versions and would have to buy the brand-name medicines instead.

• •FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list
• •Federal Register notice dated 4/30/2026 covers the proposal
• •Action targets bulk substances used by outsourcing facilities to compound copies

The FDA is moving to stop pharmacies from making their own copies of weight-loss drugs like semaglutide and tirzepatide. The agency says there's enough of the name-brand versions available, so compounding isn't needed.

• •FDA wants to block pharmacies from compounding semaglutide and tirzepatide copies
• •Agency says brand-name supply is now enough to meet demand
• •Move targets weight-loss drugs made by compounding pharmacies