GLP-1 injections recalled nationwide — what to know about the affected products

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An unexpected shot of bad news.

A popular weight-loss shot has been recalled across the country by the FDA due to potential contamination.

The US-based compounding pharmacy that issued the initial recall back in September had already been on the agency’s radar and previously received a warning.

Apothecary Pharma, a compounding pharmacy based in North Carolina, is recalling 22 vials of their compounded tirzepatide, the active ingredient in Mounjaro and Zepbound, though these brand name drugs aren’t affected by the recall.

Even if you didn’t buy directly from Apothecary Pharma, your medication could still be affected.

The company reportedly supplies compounded tirzepatide to several telehealth providers, so check your vial’s label for the manufacturer and lot number.

Recalled vials are labeled 18 mg/mL in a 4 mL multi-dose vial.

Apothecary Pharma is also recalling a NAD+ injection, a popular longevity supplement, for possible contamination.

Both recalls are Class II, which means that using these products could cause “temporary or medically reversible adverse health consequences” though severe health consequences are unlikely.

Previous warning and possible contamination

This is not the first time the FDA has disciplined Apothecary Pharma for this reason.

In December, they issued a warning letter to the company after an inspection found “serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.”

The FDA regulates sterility at every stage of production — from cleanroom airflow and equipment cleaning to personnel gowning and filtration — not just through final-product testing.

“Lack of assurance of sterility” means the FDA cannot guarantee the product is free of contamination because of compromised sterility at some point in the production chain.

In this case, the federal agency saw operators improperly handling sterile containers, touching sterile work areas and failing to change gloves to prevent contamination, and noted visibly rusty and hard-to-clean equipment.

Concerns about compounded GLP-1s

Compounding services like Apothecary Pharma offer alternative formulations of brand-name drugs, originally for medication shortages and specialized patient needs. However, it’s become a way for manufacturers to get around strict FDA regulations and offer steep discounts.

While most people on GLP-1s use the brand name stuff, as many as 5 million are on compounded versions. Many people get these compounded versions through telehealth companies, which ship them directly to patients.

Compounded drugs are not reviewed for safety, effectiveness or quality before they’re put on the market.

The FDA has flagged dosing errors from compounded GLP-1s that landed people in the hospital, improper storage that doesn’t keep them cool enough and even fraudulent compounded drugs listing a manufacturer that doesn’t exist.

The agency also expressed concerns about multi-dose vials, which were included in this recall, as they rely on patients to self-administer doses from a vial that could become contaminated, especially after 28 days.

The FDA has received more than 730 reports of bad reactions to compounded tirzepatide, the drug implicated in this recall — though they say this is likely underreported.