Compounded GLP-1 Injections Recalled Over Sterility Issues
Twenty-two vials of a compounded GLP-1 drug have been recalled. Apothecary Pharma, which had previously received a warning letter from the Food & Drug Administration, voluntarily issued the recall on Sept. 24, citing “lack of assurance of sterility.”
Two weeks later, on Oct. 8, the FDA classified the recall as Class II, meaning use of or exposure to the recalled product could cause temporary or medically reversible adverse health effects. The affected drugs contain tirzepatide, which is also the active ingredient in Mounjaro and Zepbound.
The FDA had issued a letter to Apothecary Pharma in 2025 over numerous issues, including claims that the company was not providing accurate labeling information or submitting adverse event reports. The agency also pointed to drugs being prepared and packaged in unsanitary conditions.
GLP-1 Health Concerns and Rising Lawsuits
The recall comes amidst a growing wave of concerns and lawsuits over potential health issues tied to GLP-1 products.
Eli Lilly and Novo Nordisk, the makers of Mounjaro and Ozempic, are currently battling thousands of lawsuits brought by people who say they developed severe gastrointestinal issues after using the drugs.
One of the main medical issues cited in lawsuits is gastroparesis, a form of stomach paralysis where food remains in the stomach for too long. This can cause vomiting, pain and other health problems. More than 4,000 of those cases are currently active in federal court.
Another emerging concern is the potential tie between the use of semaglutide (the active ingredient in Ozempic and Wegovy) and a heightened risk of vision loss.
A 2024 JAMA Ophthalmology study found that semaglutide users could have a significantly higher risk of developing non-arteritic anterior ischemic optic neuropathy (NAION). This is a serious condition where blood flow to the optic nerve is reduced, sometimes resulting in sudden and permanent vision loss.
The European Medicines Agency’s safety committee determined in 2025 that NAION was a rare side effect of Ozempic, Rybelsus and Wegovy. But so far in the United States, no label change has been made to warn users of a potential risk involving Ozempic and NAION.
Hundreds of people who say they developed NAION after using these drugs have now filed GLP-1 lawsuits both in federal court and in New Jersey, the home of Novo Nordisk’s U.S. headquarters.
The NAION lawsuits remain relatively new, with litigation still in the early stages of discovery. More cases are expected to be filed.
Attorney Ellen Relkin, a partner and chair of the defective drug and devices practice group at Weitz & Luxenberg, told Drugwatch that NAION cases involving compounding pharmacies may be more challenging to litigate.
“The primary litigations are against the name brand,” said Relkin, who is the court-appointed co-lead counsel in the New Jersey semaglutide litigation. “Our firm at this point are only handling the semaglutides, so Wegovy and Ozempic. We have not handled those cases, but I do think it’s a big public health issue, so we would consider looking at those cases as well.”