Some GLP-1 injections recalled due to ‘lack of assurance of sterility’
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Dozens of vials of compounded GLP-1 injections have been recalled due to a lack of assurance that the products are sterile, according to the U.S. Food and Drug Administration.
The compounding pharmacy that issued the recall was previously reprimanded by the FDA for “serious deficiencies” in their practices.
Here’s what you need to know.
Use of blockbuster anti-obesity drugs like Wegovy and Zepbound is growing, with about 1 in 8 adults in the U.S. saying they currently take the medications.
What’s being recalled
Apothecary Pharma, a compounding pharmacy, voluntarily recalled 22 vials of Tirzepatide injections last month due to a “lack of assurance of sterility,” according to the official announcement.
The recall classification was updated this month to Class ll — meaning exposure to the product may cause temporary or medically reversible adverse health consequences. However, the probability of serious adverse health effects is still considered low.
The FDA previously sent Apothecary Pharma a warning letter in December stating that the company failed to properly label the drug at its outsourcing facility in North Carolina.
Some of the labels did not include:
- Active ingredients
- Quantity of each ingredient
- Information to facilitate adverse event reporting
- Directions for use, including, as appropriate, dosage and administration
Over the course of several inspections in September 2024, and three visits in January and May 2025, “investigators noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk,” according to the FDA’s December letter.
Specific code information on the recalled products can be found here.
U.S. inspectors found egregious conditions at two Chinese factories making key components for compounded GLP-1 drugs popular in America, including black mold and “gross contamination” at one plant.
What are compounded GLP-1s?
A compounded GLP-1 is made when a pharmacy formulates a custom-made version or copy of the drug.
Injections of GLP-1s, or Glucagon-like peptide-1 receptor agonists in technical terms, were initially prescribed for people with diabetes, according to the U.S. Centers for Disease Control and Prevention.
The medication aided in lowering blood sugar levels, weight loss and decreasing the risk of cardiovascular disease for those with obesity or Type 2 diabetes — whose bodily systems were often dysregulated, which made it harder for them to manage their blood sugar and appetite.
GLP-1 medications are designed to mimic a natural hormone that the body already produces, giving a person an extra boost of the “I’m full” hormone, according to Stanford Medicine clinicians.
Their use has exploded in the last three years, however, despite a sometimes-hefty price tag without insurance coverage — around $1,000 a month on the higher end.
Surging demand for the medication, a shortage in production from mainstream manufacturers, along with a desire to pay less for it, has made room for the creation of compounded GLP-1s.
Public health officials have expressed concerns about compounded GLP-1 medication because, unlike-FDA approved drugs that include brand-name and generic drugs, the compounded drugs don’t go through the agency’s regulatory review process for safety, effectiveness or quality, according to Stanford Medicine.
Pharmacies received the green light to create the compounded drug when a GLP-1 shortage began in 2022 — with the stipulation that the drugs could be manufactured only during a shortage.
A majority of the drug shortages have ended, but compounding pharmacies haven’t scaled down, regulators say.
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