New Delhi: A compounding pharmacy, following a notice by the US FDA, has recalled 22 vials of compounded tirzepatide injections across the US over concerns that their sterility could not be assured. This has raised questions about the safety of injectable weight-loss drugs prepared by pharmacies rather than approved drug manufacturers.
Compounded GLP-1 drugs are versions of medicines, such as semaglutide and tirzepatide, prepared by pharmacies instead of supplied as finished products by the original manufacturers. Unlike approved drugs, they have not undergone the same FDA review for safety, effectiveness and quality before reaching patients.
Apothecary Pharma, the pharmacy which has recalled the vials, is treated by the US Food and Drug Administration as an outsourcing facility under US law.
Compounding pharmacies prepare medicines tailored to individual patients on a prescriber’s order, instead of selling mass-produced, factory-made drugs. A patient may, for example, need a formulation without a particular ingredient or a dose that is not commercially available. Outsourcing facilities can also make larger batches of sterile medicines, such as injectables, for clinics and pharmacies.
The voluntary recall by US-based Apothecary Pharma began on 24 September, and was classified as a Class II recall by the US FDA. This category applies when a product may cause temporary or medically reversible health problems, with the likelihood of serious harm considered low.
Tirzepatide is the active ingredient in Mounjaro, used to treat type 2 diabetes, and Zepbound, approved in the US for weight management. The recalled product was a compounded version of the drug, supplied in multidose vials containing 18 mg/ml of tirzepatide.
The recall was reported by USA Today on 19 October, following an FDA notice. It also covers one vial of the company’s compounded nicotinamide adenine dinucleotide (NAD+) injection.
The latest recall is not the first involving compounded GLP-1 drugs. The FDA previously classified as Class II a recall of more than 36,000 vials of compounded semaglutide injections from ProRx LLC, another compounding facility, over a lack of assurance of sterility. The company had begun that recall in October 2025. Other compounded GLP-1 products have also faced recalls or safety alerts linked to manufacturing concerns.
What prompted the recall?
The FDA’s stated reason in its notice was a lack of assurance of sterility.
Sterility means that an injectable medicine is free from living microorganisms, such as bacteria and fungi, that could cause infections. Unlike tablets taken by mouth, injections bypass some of the body’s natural barriers to infection, making contamination a particular concern.
The tirzepatide recall covers lots AP-202622 through AP-202644, with beyond-use dates ranging from 7 October to 26 November.
The FDA notice does not mention any reported injuries or illnesses linked to the recalled products.
The recall also comes after scrutiny of the company’s manufacturing practices. In a warning letter dated 1 December, 2025, the FDA had said that investigators who inspected Apothecary Pharma’s facility in Cary, North Carolina in May 2025 had found serious deficiencies in its procedures for producing sterile drugs.
According to the letter, the company stopped sterile production on 12 May last year and informed the FDA that it planned to resume production on 1 August, 2025. The warning letter concerned the facility’s drug-manufacturing practices. It does not, by itself, establish the cause of the latest recall.
ThePrint has reached out to the FDA and Apothecary Pharma for comments. This report will be updated if and when a response is received.
Why are compounded GLP-1 drugs under scrutiny?
In the US, certain facilities can also prepare larger quantities of sterile medicines under specific regulatory provisions. However, compounded drugs are not reviewed and approved by FDA in the same way as commercially manufactured medicines. This means the agency has not established their safety, effectiveness and quality through the standard approval process before they reach patients.
Compounded versions of drugs, such as tirzepatide and semaglutide, became more widely available during shortages of their approved counterparts. FDA’s shortage-related policies allowed compounding under specific conditions, and the agency subsequently restricted routine copies as the shortages ended.
Many compounders kept making versions of tirzepatide and semaglutide, even after the agency removed both from its shortage list—a change that came in stages between late 2024 and early 2025, USA Today reported.
(Edited by Mannat Chugh)
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