SAFETY
10 July 2026
FDA adverse event database, 2025 · Stanford Medicine, July 2026
455+ adverse events, 320+ hospitalisations: the FDA’s patient safety case against compounded GLP-1s
FDA adverse event data shows over 455 reports linked to compounded semaglutide and 320 tied to compounded tirzepatide, many involving hospitalisation due to dosing errors from multi-dose vials. A 2026…
SA RECALL
9 July 2026
Mail & Guardian, 9 July 2026 · Reuters, 9 July 2026
SAHPRA recalls iDexis GLP-1 products — healthcare professionals warned of disciplinary action
South African health regulators have issued a Class I, Type A recall of iDexis semaglutide and tirzepatide products and warned doctors and pharmacists that continued prescribing or dispensing could result…
SAFETY
8 July 2026
Joburg ETC
SAHPRA, SAPC and HPCSA issue Class I recall of iDexis semaglutide and tirzepatide products
South Africa's three major health regulatory bodies issued a joint Class I, Type A recall — the most serious safety alert level — of iDexis semaglutide and tirzepatide products, warning…
COURT RULING
24 June 2026
Courthouse News Service. Fifth Circuit probes FDA ban on compounded GLP-1s. March 30, 2026 · ArentFox Schiff. The Shot Heard 'Round the Pharmacy: FDA Takes Aim at GLP-1 Compounders. May 2026
Fifth Circuit grills FDA on whether banning compounded GLP-1s was legal at all
Judges on the US Court of Appeals for the Fifth Circuit questioned the legal foundations of the FDA's compounding ban during oral arguments that observers described as unusually pointed. The…
SAFETY
23 June 2026
FDA. Adverse event reports: compounded semaglutide and tirzepatide. As of early 2025 · Pharmacy Times. FDA Moves to Permanently Close the Door on Compounded GLP-1s. June 2026
455+ adverse events, dosing errors and counterfeit APIs: the safety case against compounded GLP-1s
As the legal and regulatory battle over compounded GLP-1s intensifies, the FDA has been building a parallel public health case based on real-world harm data. The numbers are striking: as…
INDUSTRY
22 June 2026
Pharmacy Times. FDA and Novo Nordisk Warned of GLP-1 Telehealth Compounding Takedown. February 2026 · FDA Warning Letter to Hims & Hers CEO Andrew Dudum. September 2025
Novo Nordisk sues Hims & Hers over compounded semaglutide — and the “inauthentic API” allegation
On 9 February 2026, Novo Nordisk filed a federal patent infringement lawsuit against Hims & Hers Health, the publicly traded telehealth company, alleging it had continued to mass-compound injectable semaglutide…
SA RELEVANCE
21 June 2026
SAHPRA. Medicines and Related Substances Act, 1965 (Act 101 of 1965), as amended · FDA. Import alert: unverified GLP-1 active pharmaceutical ingredients. September 2025
What the US compounding crackdown means for South African patients sourcing GLP-1s online
South Africa does not have a compounding industry for GLP-1 medications at the scale that existed in the United States during the shortage period. The Medicines and Related Substances Act…