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. <\/p>\n
The compounding pharmacy that issued the recall was previously reprimanded by the FDA for \u201cserious deficiencies\u201d in their practices. <\/p>\n
Here\u2019s what you need to know.<\/p>\n
What\u2019s being recalled<\/p>\n
Apothecary Pharma, a compounding pharmacy, voluntarily recalled 22 vials of Tirzepatide injections last month due to a \u201clack of assurance of sterility,\u201d according to the official announcement<\/a>. <\/p>\n The recall classification was updated this month to Class ll<\/a> \u2014 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. <\/p>\n The FDA previously sent Apothecary Pharma a warning letter in December<\/a> stating that the company failed to properly label the drug at its outsourcing facility in North Carolina. <\/p>\n Some of the labels did not include: <\/p>\n Active ingredients Quantity of each ingredientInformation to facilitate adverse event reportingDirections for use, including, as appropriate, dosage and administration<\/p>\n Over the course of several inspections in September 2024, and three visits in January and May 2025, \u201cinvestigators noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk,\u201d according to the FDA\u2019s December letter. <\/p>\n Specific code information on the recalled products can be found here<\/a>. <\/p>\n What are compounded GLP-1s?<\/p>\n A compounded GLP-1 is made when a pharmacy formulates a custom-made version or copy of the drug.<\/p>\n 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<\/a>. <\/p>\n 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 \u2014 whose bodily systems were often dysregulated, which made it harder for them to manage their blood sugar and appetite. <\/p>\n GLP-1 medications are designed to mimic a natural hormone that the body already produces, giving a person an extra boost of the \u201cI\u2019m full\u201d hormone, according to Stanford Medicine clinicians<\/a>. <\/p>\n Their use has exploded in the last three years, however, despite a sometimes-hefty price tag without insurance coverage \u2014 around $1,000 a month<\/a> on the higher end.<\/p>\n 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.<\/p>\n 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\u2019t go through the agency\u2019s regulatory review process for safety, effectiveness or quality, according to Stanford Medicine<\/a>. <\/p>\n