Dozens of vials of compounded GLP-1 injections have been pulled from the market after the manufacturer could not guarantee they were sterile, according to the U.S. Food and Drug Administration. The recall affects people who use compounded versions of popular weight loss and diabetes drugs, often because they are cheaper than brand-name options or because of ongoing shortages. As your consumer watchdog, I track these kinds of recalls closely so you can catch a problem before it reaches your medicine cabinet.
The pharmacy behind the recall, Apothecary Pharma, voluntarily pulled 22 vials of Tirzepatide injections last month, citing a "lack of assurance of sterility," according to the official announcement. This month, the FDA updated the recall to a Class II classification, meaning exposure could cause temporary or medically reversible health problems, though the agency says the chance of serious harm remains low.
This is not the company's first run-in with federal regulators. The FDA sent Apothecary Pharma a warning letter in December after inspectors found the company had failed to properly label its drugs at its outsourcing facility in North Carolina.
How to spot it
- Labels on the recalled products did not include active ingredients
- Labels were missing the quantity of each ingredient
- Labels lacked information needed to report adverse events
- Labels did not include directions for use, including dosage and administration
- FDA inspections in September 2024 and again in January and May 2025 found what the agency called "serious deficiencies" in the company's sterile production practices
What to do if it happened to you
The FDA has posted specific code information for the recalled vials so consumers can check whether their product is affected.
Compounded GLP-1s are custom versions of drugs like Tirzepatide, created by pharmacies rather than major manufacturers. GLP-1s, known formally as Glucagon-like peptide-1 receptor agonists, were originally prescribed for diabetes patients and work by mimicking a hormone that signals fullness, according to the CDC and Stanford Medicine. Their popularity has surged in the past three years despite price tags that can reach around $1,000 a month without insurance, fueling demand for cheaper compounded alternatives.
Public health officials have raised concerns about these compounded versions because, unlike FDA-approved brand-name and generic drugs, they do not go through the agency's full safety and quality review process, according to Stanford Medicine. Pharmacies were allowed to produce compounded GLP-1s starting in 2022 because of a shortage, with the understanding that the practice would continue only while the shortage lasted. Regulators note that although most shortages have since eased, compounding pharmacies have not scaled back production.
Source: Los Angeles Times
