The risk picture, straight from the source — reported side effects, recalls, contamination, and safety signals worth knowing about before you buy or use.
As of May 31, 2026, the FDA reported 990+ adverse-event reports tied to compounded semaglutide and 730+ for other compounded GLP-1 products, citing risks from unapproved, non-sterile, or misbranded copycat products. The agency reiterated that compounded versions lack an FDA-approved-quality assurance.
The FDA's 2024-2025 updates to the Ozempic and Wegovy (semaglutide) prescribing information added warnings for ileus/intestinal blockage, pulmonary aspiration during anesthesia, and ongoing gastroparesis surveillance, reflecting accumulating postmarketing reports - including roughly 20 ileus reports with two deaths. A 2025 observational study found an increased gastroparesis incidence in semaglutide users versus a comparator weight-loss drug, and federal GLP-1 gastroparesis litigation (MDL 3094) has consolidated hundreds of claims. The label changes underscore that delayed gastric emptying - the drug's mechanism - has real downstream safety consequences that prescribers must manage.
In April 2025 Pfizer discontinued development of the oral GLP-1 receptor agonist danuglipron for chronic weight management after late-stage trials revealed a drug-induced liver injury (DILI) signal with elevated liver enzymes. The decision ended a years-long effort to field a small-molecule GLP-1 pill and came after an earlier once-daily formulation had already been shelved in 2023 for the same reason. The exit narrows the oral GLP-1 race to Lilly's orforglipron and Novo Nordisk's oral semaglutide, and it is a cautionary safety case for the broader peptide-therapeutics field on hepatotoxicity surveillance.
On April 14, 2025, the FDA warned consumers and healthcare providers not to use counterfeit Ozempic (semaglutide) 1 mg injection that had entered the US drug supply chain after Novo Nordisk reported several hundred suspect units. The agency flagged risks of wrong active ingredient, incorrect dose, and contamination, and advised the supply chain to quarantine and verify the implicated lot. The alert sits atop a broader body of evidence - including pharmacovigilance analyses of suspected-counterfeit semaglutide where ~89% of reported adverse drug reactions were classified as serious (vomiting, nausea, hypoglycemia) - underscoring that the GLP-1 boom has spawned a parallel counterfeit and illicit-compounding safety problem.