Nationwide Recall of Compounded GLP-1 Injections Raises Safety Questions
The U.S. Food and Drug Administration reported that Apothecary Pharma LLC, based in Cary, North Carolina, has voluntarily recalled specific lots of compounded tirzepatide injections. Tirzepatide is the active ingredient in the brand-name drugs Mounjaro and Zepbound; this compounded version added niacinamide. The recall reason is a "lack of assurance of sterility" — the manufacturer could not demonstrate that the injections remained sterile during production. The recall was initiated September 24 and classified Class II on October 8, appearing in the FDA's October 14 enforcement report. It covers 22 vials of compounded tirzepatide plus one vial of compounded NAD+ injection, all distributed nationwide.
The FDA classified the recall as Class II, meaning use of the medication could cause "temporary or medically reversible adverse health consequences," though the risk of serious harm is small. The FDA's position is that while the risk is low, a lack of sterility assurance for injectable drugs is a serious deficiency, because injections bypass the skin's natural barrier. A sterility recall does not mean every affected vial is contaminated; it means the maker could not show its process reliably kept the drug free of germs. Apothecary Pharma notified customers by letter rather than through a public announcement.
Apothecary Pharma is no stranger to FDA scrutiny. The agency sent the company a warning letter in December 2025, following a May 2025 inspection that found "serious deficiencies" in practices for producing drugs intended to be sterile, saying the lapses put patients at risk. The FDA allowed compounding pharmacies to produce GLP-1 drugs during the shortage starting in 2022, but after tirzepatide and semaglutide were removed from the official drug shortage list in late 2024 and early 2025, compounders were expected to stop mass production. Many kept operating, selling compounded drugs through telehealth platforms, clinics and medical spas, reaching well beyond traditional pharmacies.
The recall applies only to specific Apothecary Pharma lots and does not affect FDA-approved Mounjaro or Zepbound. The recalled tirzepatide vials contain 18 mg/ml tirzepatide in 4 ml sterile multi-dose vials under NDC 85091-001-18, in lots AP-202622 through AP-202625 and AP-202627 through AP-202644 (lot AP-202626 is notably absent), with beyond-use dates from October 7 through November 26. One vial of NAD+ injection, 200 mg/ml in a 6 ml sterile multi-dose vial (NDC 85091-011-06, lot AP-202647), was recalled for the same reason. Patients can check whether their vial is affected by matching the lot number and beyond-use date on the label.
Patients should check the lot number and beyond-use date on their vial label. If it matches an affected lot, stop using the product and contact your prescriber for instructions on disposal. The FDA has also issued a safety alert noting that some patients using compounded semaglutide have required hospitalization after taking incorrect doses, with reported complications including severe gastrointestinal symptoms, dehydration, fainting, and acute pancreatitis. Compounded medications are not FDA-approved and do not undergo the same quality controls as brand-name drugs. Patients with questions about their medication's source should consult their doctor or pharmacist.