A tirzepatide recall from compounding company Apothecary Pharma LLC covers 22 vials of a GLP-1 injection distributed nationwide, and the Food and Drug Administration classified it as a Class II recall on Oct. 8, USA Today reported Monday. The company started the voluntary recall Sept. 24 because it couldn’t assure the vials were sterile.
Tirzepatide is the active ingredient in Eli Lilly’s brand-name drugs Zepbound and Mounjaro, but neither is part of this recall. The recalled product is a compounded version, meaning Apothecary Pharma mixed it itself. Unlike Zepbound and Mounjaro, it never went through the FDA’s approval process.
What happened with the tirzepatide recall
The recall covers Apothecary Pharma Tirzepatide Injection, 18 milligrams per milliliter, in 4-milliliter multidose vials sold by prescription only. The FDA lists the recalled quantity as 22 vials, though USA Today noted the notice also lists 22 lot numbers and asked the agency to clarify whether the figure refers to vials or lots. The same recall includes one vial of the company’s NAD+ injection.
Class II is the middle tier of the FDA’s recall system. It applies when using a product could cause temporary or medically reversible health problems, and the chance of serious harm is remote.
The recall comes about 10 months after the FDA sent Apothecary Pharma a warning letter, dated Dec. 1, 2025, citing serious deficiencies in how the company produced sterile drugs. The letter followed a May 2025 inspection of its Cary, North Carolina, facility. The agency hasn’t publicly connected those findings to the current recall.
What it means for people using compounded GLP-1s
Because compounded drugs skip the FDA approval process, the agency doesn’t review the finished products for safety, effectiveness or quality before patients use them. Many compounding pharmacies answer mainly to state pharmacy boards, and USA Today reported that limited federal oversight has opened the door to sanitation and contamination problems in the industry.
Apothecary Pharma sits in a different category. It’s registered with the FDA as a 503B outsourcing facility, a type of compounder that must meet federal manufacturing standards and is subject to FDA inspections. One of those inspections led to last year’s warning letter.
If you use compounded tirzepatide, check your vial label for these details:
- NDC 85091-001-18
- Lot numbers AP-202622 through AP-202625 and AP-202627 through AP-202644
- Beyond-use dates between Oct. 7 and Nov. 26, 2026
Apothecary Pharma notified customers by letter, according to the FDA. Neither the agency nor the company has publicly said how recalled vials should be returned or thrown away, so check with the pharmacy or prescriber who supplied your vial before using it.
Background on compounded GLP-1 scrutiny
Compounders were allowed to make copies of tirzepatide and semaglutide while both drugs sat on the FDA’s shortage list. That window closed after the agency declared the tirzepatide shortage resolved in late 2024 and the semaglutide shortage resolved in February 2025. Oversight has kept tightening since. In April, the FDA proposed removing semaglutide, tirzepatide and liraglutide from the list of bulk ingredients outsourcing facilities can use, according to Becker’s Hospital Review.
Interest in the drugs keeps growing beyond weight loss and diabetes, too. CNN reported Oct. 13 on early research suggesting GLP-1 medications may slow the body’s biological aging.
What’s next
The recall remains open. The FDA hasn’t announced an expansion, and no illnesses have been publicly linked to the recalled vials. Anyone with a vial from the affected lots should hold off on using it and contact their pharmacy or prescriber.
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