GLP-1 medication Tirzepatide recalled over safety and sterility concerns

The FDA has announced that Apothecary Pharma is recalling 22 vials of injectable Tirzepatide distributed across the US after concerns were raised.

Tirzepatide has surged in popularity for its weight loss benefits in recent years, but growing demand for the drug has also highlighted the importance of medication safety.

North Carolina-based pharmaceutical company Apothecary Pharma is currently recalling the drug, which is used to treat type 2 diabetes but has become increasingly popular for its weight loss benefits.

The recall was issued after the company was unable to guarantee the sterility of the affected products, raising concerns about the potential risks to patients who may have already used the injections, as per Fox Business.

Sterility is particularly important for injectable medications, as contaminated products can introduce harmful microorganisms directly into the body and potentially lead to serious infections or other complications.

Tirzepatide is currently involved in a voluntary recall. (Getty Stock Images)

The FDA regularly publishes recall notices to alert healthcare professionals and consumers to potential safety issues involving medications, and this particular recall comes after a December 2025 warning letter that states problems put patients at risk.

However, it has not established a connection between those findings and the current voluntary recall.

Tirzepatide has grown significantly in popularity in recent years, with the drug currently being sold under brand names including Mounjaro and Zepbound.

However, the recalled vials are associated with Apothecary Pharma, and the recall notice relates specifically to the affected products.

It specially affects prescription tirzepatide injections supplied in 4 mL multidose vials at a concentration of 18 mg/mL, carrying the National Drug Code (NDC) 85091-001-18.

It's commonly sold under brand names including Mounjaro and Zepbound. (Getty Stock Images)

Anyone experiencing a fever, redness, swelling or worsening pain after an affected injection have been advised to seek medical advice as a result.

People using tirzepatide for weight management may begin to notice changes within the first few weeks of treatment, although the amount of weight lost and how quickly results appear can vary significantly from person to person.

Health experts explain that the drugs works by mimicking hormones involved in regulating appetite and blood sugar levels, helping people feel fuller for longer and reducing hunger. Weight loss is generally gradual rather than immediate, with results building over several months as treatment continues.

Following the recent warning, those who believe they may have received medication included in the recall should check the relevant product details and contact a healthcare professional for advice on what to do next.

However, Apothecary Pharma says it has already notified recipients by letter.

UNILAD have reached out to Eli Lilly for comment.