FDA officials announced a nationwide recall of an injectable medication found in many compounded GLP-1 drugs that are widely used as alternatives to more expensive brand-name prescriptions.
Apothecary Pharma LLC issued a voluntary recall on dozens of its tirzepatide injections on Sept. 24 over concerns the products could contain contaminants including microbes, according to a notice from the US Food and Drug Administration.
The recall, which impacts 22 lots of compounded GLP-1s, comes as the weight loss drug alternatives, which are not FDA approved, have come under increased scrutiny by federal regulators.
Mounjaro and Zepbound, FDA-approved brand-name versions of tirzepatide shots, aren’t affected by the recall.
The FDA defines compounding as when a licensed pharmacist, or registered outsourcing facility, mixes or alters drug ingredients, often to create boutique prescription medications for patients who may not be served by brand-name options.
Compounded medications are not the same as FDA-approved generic drugs, the agency has said.
Apothecary Pharma LLC was among thousands of pharmacies and facilities allowed to produce less expensive, non-FDA-approved versions of GLP-1 drugs during a nationwide shortage of the medications when demand surged in 2022, according to the FDA.
Production of GLP-1 alternatives using semaglutide, an ingredient in Ozempic and Wegovy, was also permitted during the shortage. That shortfall ended in 2025 and compounded production was supposed to cease, according to the FDA, though many producers have continued making compounded GLP-1s with additional ingredients as a way to skirt the ban, according to a study in the Journal of the American Medical Association.
The popularity of boutique GLP-1 alternatives has outlived the shortage, driven in large part by their significant savings for patients.
In 2024, roughly 1 in 3 GLP-1 patients were using these kinds of alternatives, according to KFF Health News. Now the figure is around 1 in 5 according to a July Gallup report, as GLP-1 usage has continued to soar nationwide.
The FDA officially warned patients not to use compounded GLP-1s this month unless an individual’s medical needs cannot be met by the name-brand drugs. The agency cited reports of improper storage during shipping and dosing errors that have led to adverse reactions, sometimes requiring hospitalization. Some products, the FDA said, were being made with unapproved ingredients.
On Oct. 8, the FDA formally classified the Apothecary Pharma LLC recall as presenting only a “remote” possibility of serious adverse health consequences. In March, the agency warned the company that investigators “noted serious deficiencies” in sterility protocols, placing “patients at risk.”
In the notice, the FDA did not say whether the recalled injections were contaminated, or what patients should do with their vials.
Officials from the FDA and Apothecary Pharma LLC did not respond to a request for comment Wednesday.
This year, the FDA has also issued warning letters against many small pharmacies for promoting their compounded products as being the same as the brand-name labels.
Drug makers like Eli Lilly have sued to block continued production of GLP-1 alternatives, NPR reported.
The FDA said the following compound lots, which were available by prescription only and sold in 18mg/mL and 4 mL sterile multi-dose vials, are subject to the ongoing nationwide recall:
- Lot AP-202622, BUD 07-Oct-2026
- Lot AP-202623, BUD 08-Oct-2026
- Lot AP-202624, BUD 19-Oct-2026
- Lot AP-202625, BUD 10/20/2026
- Lot AP-202627, BUD 10/26/2026
- Lot AP-202628, BUD 10/27/2026
- Lot AP-202629, BUD 10/28/2026
- Lot AP-202630, BUD 10/31/2026
- Lot AP-202631, BUD 11/01/2026
- Lot AP-202632, BUD 11/03/2026
- Lot AP-202633, BUD 11/07/2026
- Lot AP-202634, BUD 11/08/2026
- Lot AP-202635, BUD 11/16/2026
- Lot AP-202636, BUD 11/17/2026
- Lot AP-202637, BUD 11/18/2026
- Lot AP-202638, BUD 11/19/2026
- Lot AP-202639, BUD 11/20/2026
- Lot AP-202640, BUD 11/21/2026
- Lot AP-202641, BUD 11/22/2026
- Lot AP-202642, BUD 11/24/2026
- Lot AP-202643, BUD 11/25/2026
- Lot AP-202644, BUD 11/26/2026
Bryan Hecht can be reached at bryan.hecht@globe.com. Follow him on Instagram @bhechtjournalism.