GLP-1 injections pulled nationwide for worrying cause

The FDA has issued a nationwide recall of a widely used weight-loss injection over contamination concerns. The recall was initiated in September by a North Carolina-based compounding pharmacy, Apothecary Pharma, which had already drawn scrutiny from the agency and received a prior warning.

Which Products Are Affected

The pharmacy is pulling 22 vials of compounded tirzepatide — the active ingredient found in Mounjaro and Zepbound — though the brand-name versions of these drugs are not part of the recall. Even patients who did not purchase directly from Apothecary Pharma may still be affected. The company reportedly provides compounded tirzepatide to multiple telehealth providers, so consumers should inspect their vial's label for the manufacturer and lot number. The recalled vials are labeled 18 mg/mL in a 4 mL multi-dose format. Additionally, Apothecary Pharma is recalling a NAD+ injection, a popular longevity supplement, due to possible contamination. Both recalls are classified as Class II, meaning use of these products could result in "temporary or medically reversible adverse health consequences" although serious health outcomes are unlikely.

Prior FDA Warning

This marks the second time the FDA has taken disciplinary action against Apothecary Pharma over the same issue. In December, the agency sent the company a warning letter following an inspection that uncovered "serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk." The FDA oversees sterility throughout the entire manufacturing process — including cleanroom airflow, equipment sanitation, personnel gowning and filtration — rather than relying solely on final-product testing. A finding of "Lack of assurance of sterility" indicates the agency cannot confirm the product is contamination-free because sterility was compromised somewhere in the production chain. In this instance, federal inspectors observed operators mishandling sterile containers, contacting sterile work surfaces and neglecting to change gloves to prevent contamination. They also documented equipment that was visibly rusty and difficult to clean.

Risks of Compounded GLP-1s

Compounding services such as Apothecary Pharma produce alternative formulations of brand-name medications, a practice that originally emerged to address drug shortages and meet specialized patient needs. Over time, however, it has become a route for manufacturers to circumvent stringent FDA oversight and offer significant discounts. While the majority of GLP-1 users rely on brand-name products, an estimated 5 million people are taking compounded versions. Many obtain these through telehealth companies that ship directly to patients. Compounded drugs are not evaluated for safety, effectiveness or quality before reaching the market. The FDA has identified dosing errors linked to compounded GLP-1s that resulted in hospitalizations, improper storage that failed to maintain adequate refrigeration and even fraudulent compounded drugs bearing the name of a manufacturer that does not exist. The agency has also raised concerns about multi-dose vials — the type included in this recall — because they depend on patients self-administering doses from a vial that may become contaminated, particularly beyond 28 days. More than 730 reports of adverse reactions to compounded tirzepatide — the drug involved in this recall — have been submitted to the FDA, though the agency notes this figure is likely an undercount.