Apollo Care Recalls More Than 162,000 Vials of Compounded Semaglutide Nationwide After Particulate Matter Found

A compounded weight-loss and diabetes injectable that reaches many patients through telehealth is the subject of a large safety recall. Apollo Care, LLC, an FDA registered 503B outsourcing pharmacy in Columbia, Missouri, is voluntarily recalling more than 162,000 multi-dose vials of compounded semaglutide nationwide after particulate matter was identified in the product. Because compounded semaglutide is frequently prescribed and shipped through online weight-loss platforms and clinics, the recall is relevant to a broad group of patients who may not know which pharmacy prepared their medication.

What was recalled

The recall covers compounded semaglutide made by Apollo Care, LLC, a facility registered with the FDA as a 503B outsourcing pharmacy. According to recall reporting, the action covers about 156,611 multi-dose vials of compounded semaglutide in various strengths, plus about 5,500 multi-dose vials of a compounded semaglutide with glycine combination, for a total of more than 162,000 vials. The affected batches carry expiration dates in August, November and December 2026. The recall is described as voluntary and nationwide, and the firm initiated it on July 29, 2026.

Semaglutide is the active ingredient in Novo Nordisk's branded products Ozempic (for type 2 diabetes) and Wegovy (for weight management). The glycine combination pairs the drug with glycine, an amino acid that some compounders market as a way to help preserve muscle mass during weight loss. Compounded versions are not FDA approved products; they are prepared by pharmacies rather than manufactured and reviewed as finished drugs.

Why it was recalled

The stated reason for the recall is the presence of particulate matter in the vials. According to recall reporting, the particles were identified as nylon/polyamide and silk/proteinaceous-type material. Semaglutide is given by injection, and regulators treat visible or sub-visible particulate in an injectable product as a quality defect because injected particles can, in general, provoke local reactions or immune responses and, less commonly, more serious events. That is a description of why particulate is treated as a defect in injectable drugs generally; it is not a statement that any specific patient who used the recalled product has been harmed.

What a Class II recall means

The FDA sorts recalls into three classes by the level of hazard. A Class II recall, the middle tier, is defined by the agency as a situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or in which the probability of serious adverse health consequences is remote. The Apollo Care semaglutide recall has been classified as Class II. A recall classification reflects the FDA's assessment of potential risk from the defect; it is not a finding that harm has occurred, and it does not by itself establish that the medication in any individual patient's possession caused an injury.

The February 2026 warning letter and prior inspection

The recall follows earlier FDA scrutiny of the same facility. In a warning letter dated February 2, 2026, the FDA cited Apollo Care for sterility concerns and unsanitary conditions identified during a 2025 inspection of the Columbia, Missouri site. As reported, the warning letter described white, fiber-like particles and debris observed at the facility, including on floors after cleaning. The FDA returned to inspect the facility again in late July 2026 and issued a Form FDA 483, the list of inspection observations investigators leave with a firm; as of this writing that 483 has not been made public.

A warning letter and a Form FDA 483 are steps in the FDA's compliance process. A 483 records observations from an inspection, and a warning letter sets out violations the agency believes it has found and asks for correction. Neither is a final court judgment, and the firm can respond and make changes. The recall is a separate, firm-initiated action, but it sits against that documented backdrop of sterility and particulate concerns at the facility.

Why this matters for telehealth weight-loss patients

503B outsourcing facilities like Apollo Care supply compounded medications in bulk to clinics and providers, which then dispense or administer them to patients. Compounded semaglutide surged in use during recent shortages of branded GLP-1 drugs and is often prescribed through online weight-loss programs and telehealth clinics, then shipped to patients or given in office. In that model, a patient frequently does not see the name of the compounding pharmacy on the label and may be several steps removed from the facility that prepared the dose. A nationwide recall for a mailed or clinic-administered injectable therefore depends on prescribers and providers passing the notice down to the people who received the product.

What patients and prescribers can do

This is general information, not medical advice. If you use compounded semaglutide, the following steps are consistent with how the FDA advises patients to handle drug recalls and reports:

• Ask your prescriber or the clinic or telehealth program that supplied your medication whether Apollo Care, LLC was the compounding pharmacy, and whether your specific product is part of the recall.
• Do not use any injectable that contains visible particles, cloudiness or discoloration, and follow your provider's instructions about a product identified as recalled.
• Keep the vial, label and any packaging or paperwork, which can help your provider and the pharmacy match your product to affected batches.
• If you have used a recalled product and feel unwell, contact your prescribing clinician or seek medical care.
• Report any adverse event or quality problem to the FDA's MedWatch program online or by calling 1-800-332-1088.