Apollo Care recalls roughly 162,000 vials of compounded semaglutide

Apollo Care, LLC, an FDA-registered 503B outsourcing facility in Columbia, Missouri, has recalled roughly 162,000 multi-dose vials of compounded semaglutide because of particulate matter found in the vials ^[1]. The recall covers 156,611 multi-dose vials of compounded semaglutide in various strengths and 5,500 multi-dose vials of compounded semaglutide with glycine, also in various strengths, all distributed nationwide ^[1].

According to the FDA enforcement report summarized by MedShadow, the particulate was identified as nylon/polyamide and silk/proteinaceous-type material ^[1]. The recall was initiated on July 29, 2026 ^[1]. It is classified as a nationwide Class II recall, the FDA's middle category, used when a product may cause temporary or medically reversible health problems, or when serious harm is unlikely ^[1].

What was in the vials

Semaglutide is the active ingredient in the brand-name drugs Ozempic and Wegovy and is used to treat type 2 diabetes and obesity ^[1]. Compounded versions are made by pharmacies and outsourcing facilities rather than by the brand manufacturer, and they are not FDA-approved products.

The second, smaller batch combined semaglutide with glycine, an amino acid included as a dietary supplement ^[1]. Compounders sometimes add vitamins or amino acids such as glycine to semaglutide, and sellers of those versions say the added ingredient helps metabolism and supports muscle during weight loss ^[1]. Adding ingredients also creates a formulation that differs from the branded drug, which compounders may use to argue they are not simply copying an approved product ^[1].

A facility already on the FDA's radar

This is not Apollo Care's first run-in with regulators. In February 2026, the company received an FDA warning letter about sterility concerns and unsanitary conditions found during a 2025 inspection of the same Columbia, Missouri facility ^[1]. That letter noted that "white, fiber-like particles and debris" were seen on the floor of a lab and a hallway after the area had been cleaned ^[1].

The FDA inspected the Apollo Care facility again on July 28, 2026 — one day before the recall began — and issued an inspection report, Form FDA 483 ^[1]. As of the MedShadow report published August 13, 2026, no warning letter had been issued based on that inspection ^[1].

The recall fits a broader pattern in the compounded GLP-1 market. Between April and July 2025 there were four separate recalls of semaglutide and related products involving compounding pharmacies, a medical spa and a drug wholesaler ^[1]. Within the past year, three FDA-registered outsourcing facilities received FDA warning letters for unsanitary conditions and other safety lapses ^[1].

Why it matters for patients

For people using compounded semaglutide, the practical issue is knowing whether a specific vial is affected. The FDA enforcement report lists the affected lot numbers and expiration dates, and MedShadow notes that for prescription drugs without a lot number printed on the packaging, patients can ask their pharmacist whether their medication is covered by a recall ^[1].

Compounded semaglutide often reaches patients through telehealth platforms, weight-loss clinics and med spas rather than a retail pharmacy counter, which can make it harder to trace the original source of a vial. The recall total — more than 162,000 vials, each intended for multiple doses — gives a sense of how widely a single facility's product can spread before a problem is caught ^[1].

Several things are not yet known from the available reporting. The sources do not say whether anyone was injured or reported side effects linked to the particulate, how the fibers got into the vials, which specific strengths and lots are involved, or what the July 28, 2026 inspection found. The sources also do not describe what Apollo Care is telling patients or prescribers, or whether the facility has paused production.

What happens next

• February 2026: Apollo Care received an FDA warning letter over sterility concerns and unsanitary conditions tied to a 2025 inspection ^[1].
• July 28, 2026: FDA inspected the Columbia, Missouri facility and issued a Form FDA 483 ^[1].
• July 29, 2026: The recall of the semaglutide and semaglutide/glycine vials was initiated ^[1].
• August 13, 2026: As of this date, no warning letter had been issued based on the July 2026 inspection ^[1].

Whether the FDA follows the July 2026 inspection with a warning letter, and whether the recall classification changes, are the next things to watch. Questions about a specific vial or prescription are best directed to the prescriber or pharmacist who supplied it.