FDA Identifies 14 Violations at Houston Pharmacy Involved in GLP-1 Weight Loss Drug Recall
A health safety report released on October 19, 2026, unveils that Houston RX LLC, the Texas-based compounding pharmacy involved in a recent recall of injectable weight-loss drugs, was cited for 14 distinct violations by federal inspectors. These violations include instances of workers with exposed skin handling sterile medications and the utilization of research-grade ingredients in injectable formulas.
The FDA’s Form 483 inspection report discloses that federal inspectors spent six days in the North Houston facility in August 2026, documenting significant sterility and manufacturing lapses. Among the most concerning findings were an operator working inside an ISO 5 clean hood — the facility’s most sterile workspace — had exposed skin on her forehead while handling freshly filled semaglutide-niacinamide vials. Additionally, inspectors discovered that vials were stoppered by hand, finished outside the designated clean area, and equipment used for sterile drugs was not adequately sterilized. A ceiling vent near the cleanroom reportedly showed water stains and signs of potential mold.
On September 25, 2026, the pharmacy initiated a voluntary Class II recall of 64 two-milliliter vials of compounded tirzepatide-niacinamide (20 mg/2 mg per mL) — the active ingredient in the brand-name drugs Mounjaro and Zepbound — due to a lack of sterility assurance. Certificates for the tirzepatide and semaglutide active ingredients were marked for research and development use only, not for pharmaceutical use.
Health officials are urging anyone using compounded GLP-1 medications to verify their pharmacy’s compliance status with the FDA.
Source: Medical Daily – Houston Pharmacy FDA Inspection & Tirzepatide Recall