FDA Warns Compounding Pharmacy Over Sterility and Potency Failures

The FDA has issued a warning letter to Boothwyn Pharmacy, a compounding facility in Kennett Square, Pennsylvania, after an inspection found significant manufacturing problems affecting several injectable drug products, according to the FDA warning letter.

Investigators inspected the site from May to June 2025 and documented insanitary production conditions, including inadequate airflow testing in a sterile compounding area and equipment that was difficult to clean. The letter also details products that failed to meet labeled potency. A semaglutide 2.5mg/mL injection tested at just under 80 percent of its stated strength, while two lots of a tirzepatide 10mg/mL injection measured between roughly 87 and 89 percent potency. A separate combination product containing tirzepatide, glycine, and methylcobalamin failed sterility testing outright.

The FDA classifies these products as adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act, since compounded drugs must match their labeled strength and be produced under sanitary conditions to qualify for regulatory exemptions. The letter notes the pharmacy voluntarily recalled affected lots in July 2025 and temporarily paused sterile GLP-1 production before notifying the agency of plans to resume.

This case is a reminder that compounded semaglutide and tirzepatide products sold outside FDA approved channels are not standardized, and potency or sterility can vary lot to lot even at licensed pharmacies.

This article is for education only. It is not medical advice. Compounds discussed here are sold for research purposes. Talk to a licensed clinician before making health decisions.