GLP-1 injections recalled nationwide. See affected products

GLP-1 injections recalled nationwide. See affected products.

Key points

• Compounded GLP-1 injections created by a pharmacy previously cautioned by the Food and Drug Administration regarding putting "patients at risk" have been recalled nationwide.
• Apothecary Pharma LLC first initiated a voluntary recall of tirzepatide injections, the active ingredient in Zepbound and Mounjaro, on Sept.
• These factors have become increasingly controversial, with pharmaceutical giants like Eli Lilly and Novo Nordisk suing compounders to stop or limit the practice.
• This was the case in 2022 when the FDA offered compounders the go-ahead to commence producing their own versions of GLP-1 medications against the backdrop of a shortage.
• To check whether your compounding pharmacy is reputable, visit the Alliance for Pharmacy Compounding website and speak with your doctor.

GLP-1 injections recalled nationwide. See affected products. Mary Walrath-Holdridge USA TODAY. GLP-1 Injections recalled nationwide: Which products are affected?

For context, the recall covers 22 vials of medication. It are not approved by the Food and Drug Administration.

Apothecary Pharma LLC first initiated a voluntary recall of tirzepatide injections, the active ingredient in Zepbound and Mounjaro, on Sept. 24 for "lack of assurance of sterility, " according to an FDA notice. The federal agency updated the recall on Oct. 10 to classify it as a "Class II" recall, meaning using the medication could cause "temporary or medically reversible adverse health consequences." Nevertheless, the risk of serious harm is small.

In practice, the injections are compounded versions of the GLP-1, meaning they were not name-brand or FDA-approved and were custom formulated by a specialized pharmacy called a compounding pharmacy.

Sterility and sanitation problems have stirred controversy around compounding pharmacy injections previously, such as a 2012 case in which almost 800 individuals became ill and 64 died from a fungal meningitis outbreak caused by unsanitary injections from the New England Compounding Center.

Compounded GLP-1s have become a special focus of the FDA since the removal of tirzepatide and semaglutide from the official drug shortage list in late 2024 and early 2025, meaning compounding pharmacies that filled the gap for millions were projected to stop producing them en masse. Plenty of have continued, prompting the agency to problem warnings and various legal challenges.

In December 2025, Apothecary Pharma received an FDA warning letter listing a number of violations, including "serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk."

USA TODAY contacted Apothecary Pharma and the FDA for comment on Oct. 19, but has not received a response. Which compounded GLP-1 injections were recalled? A total of 22 vials of tirzepatide were recalled nationwide. What to do with recalled GLP-1 injections.

In practice, the FDA and Apothecary have not issued a public statement on what to do with affected vials; meanwhile, customers online have documented requests through their prescribers to return or dispose of them.

If you have an affected lot, do not employ it. Contact your prescriber for instructions on what to do with recalled medication. What are compounding pharmacies? Are they safe?

Compounding pharmacies, or special pharmacies that create customized versions of drugs from raw ingredients, have sparked renewed interest over recent years thanks to the surge of GLP-1s and the peptides industry.

Unlike a commercial pharmacy. It sells mass-produced drugs, a compounding pharmacy can develop specific medications to meet a patient's needs, including by adjusting the dose or removing allergens like dyes. Compounding pharmacies are often applied for pediatric and veterinary cases where a medicine needs a different format, such as a lower-concentration liquid for a small animal.

As the FDA grants temporary approval for them to produce a drug in bulk to fill the void, these pharmacies are additionally sometimes employed during drug shortages.

This was the case in 2022 when the FDA offered compounders the go-ahead to commence producing their own versions of GLP-1 medications against the backdrop of a shortage. Tirzepatide and semaglutide were removed from the official drug shortage list in late 2024 and early 2025, but compounding pharmacies have continued to produce their own versions and then sell them to millions, especially through telehealth platforms like His/Hers.

Compounding pharmacies must employ FDA-approved ingredients, but the actual formulations themselves aren't evaluated for purity, safety or effectiveness, including mass-produced medications. Compounding pharmacies additionally aren't routinely FDA-regulated. It has led to sanitation and contamination matters, such as the 2021 New England Compounding Center case or 2023 FDA reports of compounders using unapproved salt forms of ingredients in their formulations.

To check whether your compounding pharmacy is reputable, visit the Alliance for Pharmacy Compounding website and speak with your doctor. SMS Facebook Twitter Email. Share your feedback to support improve our site! Share your feedback to support improve our site!

In short, GLP-1 injections recalled nationwide. See affected products is the central thread here, and readers can expect follow-up reporting as the picture becomes clearer.