FDA Warning Letter to 503B Facility Apollo Care Cites Sterile Production Deficiencies
On February 2, 2026, FDA issued a warning letter to Apollo Care, LLC (Columbia, MO), a registered 503B outsourcing facility, citing "Adulterated Drug Products." After a March 2025 inspection, FDA noted "serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk." The letter acknowledges an April 2025 voluntary recall of a lot of fentanyl/ropivacaine epidural product due to lack of sterility assurance.
What this meansNo GLP-1 products are named, but this is another data point on quality problems across 503B outsourcing facilities — the same class of facility that produces many compounded GLP-1s.
Source: FDA original ↗