Dozens of vials of compounded GLP-1 injections have been recalled due to an inability to guarantee the sterility of the product, according to the U.S. Food and Drug Administration.
The compounding pharmacy that issued the recall had previously been reprimanded by the FDA for “seriously flawed” practices.
Here’s what you need to know.
What is being recalled
According to an official announcement, compounding pharmacy Apothecary Pharma voluntarily recalled 22 bottles of Tezepatide injection last month due to “lack of sterility assurance.”
This month the recall classification has been updated to Class II, meaning exposure to the product may cause temporary or medically reversible adverse health consequences. However, the potential for serious adverse health effects is still considered low.
The FDA previously sent a warning letter to Apothecary Pharma in December, saying the company failed to properly label the drug at its outsourced facility in North Carolina.
Some tags do not include:
- active ingredients
- Amount of each ingredient
- Messages to promote adverse event reporting
- Instructions for use, including dosage and method of administration, as appropriate
During multiple inspections in September 2024 and three visits in January and May 2025, “investigators noted serious deficiencies in your production of drug products that are intended or expected to be sterile, which put patients at risk,” according to the FDA’s December letter.
Code-specific information about recalled products can be found here.
What is compound GLP-1?
Compounded GLP-1 is created when a pharmacy formulates a customized version or copy of a drug.
Injection of GLP-1, or glucagon-like peptide-1 receptor agonist from a technical point of view, It was originally prescribed for people with diabetes, according to the U.S. Centers for Disease Control and Prevention.
The drug can help lower blood sugar levels, lose weight and reduce the risk of cardiovascular disease in people who are obese or have type 2 diabetes – people whose body systems often suffer from imbalances that make it harder to control their blood sugar and appetite.
Clinicians at Stanford University School of Medicine say GLP-1 drugs are designed to mimic the natural hormones the body already produces, giving people extra “I’m full” hormones.
However, while their price can sometimes be high without insurance – about $1,000 a month on the high end – their use has exploded in the past three years.
Surging demand for the drug, production shortages from mainstream manufacturers, and a desire to lower prices made room for the creation of compounded GLP-1.
According to Stanford University School of Medicine, public health officials are concerned about combined GLP-1 drugs because, unlike FDA-approved drugs, which include both brand-name and generic versions, they have not gone through the agency’s regulatory review process for safety, effectiveness or quality.
When the shortage of GLP-1 began in 2022, pharmacies obtained a license to produce the combination drug, with the stipulation that the drugs could only be produced during the shortage.
Regulators say most drug shortages have ended, but the size of compounding pharmacies has not yet shrunk.