Apollo Care pulls roughly 162,000 compounded semaglutide vials after particles found

Apollo Care, LLC, a compounding operation in Columbia, Missouri, recalled 156,611 vials of compounded semaglutide and 5,500 vials of a semaglutide product that also contains glycine, according to the FDA enforcement report for the action ^[1]. The recall began July 29, 2026, and covers vials sent nationwide in various strengths, bringing the two groups to roughly 162,000 ^[1].

The problem was particulate matter inside the vials, identified as nylon/polyamide and silk/proteinaceous-type material ^[1]. The FDA filed the action as a Class II recall — its middle tier, used when a product might cause temporary or medically reversible harm, or when serious harm is unlikely ^[1].

Apollo Care is registered with the FDA as a 503B outsourcing facility, a type of compounder permitted to produce sterile medicines in bulk ^[1]. Its record with the agency is not clean. In February 2026 the company received a warning letter citing sterility concerns and unsanitary conditions observed during a 2025 inspection of the same facility ^[1]. That letter described “white, fiber-like particles and debris” on a lab floor and in a hallway after cleaning ^[1]. FDA inspectors returned to the site on July 28, 2026 — the day before the recall started — and issued a Form FDA 483 inspection report; no warning letter tied to that visit has been issued so far ^[1].

Semaglutide is the molecule in the brand-name drugs Ozempic and Wegovy ^[1]. Some compounders mix in vitamins or amino acids, and glycine is one of them; sellers of the combination say it aids metabolism and helps preserve muscle during weight loss, and the extra ingredient makes the formula different from the brand-name products ^[1]. Glycine appears in the recalled vials as a dietary supplement ^[1].

The recall is not an isolated event in this corner of the market. Four separate recalls of semaglutide and related products — involving compounding pharmacies, a medical spa and a drug wholesaler — took place between April and July 2025 ^[1]. Over the past year, three FDA-registered outsourcing facilities also drew warning letters for unsanitary conditions and other safety lapses ^[1].

Why it matters for patients

Particles that end up in an injectable are a manufacturing defect, not a cosmetic one, and the agency's decision to place this recall in a category above its least serious tier reflects that ^[1].

The enforcement report lists which lots and expiration dates are affected ^[1]. When a prescription drug's packaging carries no lot number, a pharmacist can say whether a given medication falls under the recall ^[1]. Because several strengths shipped nationwide, matching the lot matters more than recognizing the product name ^[1].

Not reported: how many people received the recalled vials, whether any injuries were linked to the particles, or whether Apollo Care has halted shipments.

What happens next

The recall started July 29, 2026, and the FDA has posted the enforcement report for it ^[1]. The July 28, 2026, inspection produced a Form FDA 483, and as of the latest update no warning letter had followed ^[1]. No date has been given for further FDA action on that report.