FDA Sets Highest Risk Level for Common Over-the-Counter Drug

The FDA has designated Gas-X as Class I, the highest risk level for recalls, reflecting potential serious health consequences. Haleon recalled more than 285,000 cartons of Gas-X Extra Strength SoftGels due to incomplete inactive ingredient labeling. In a separate May 2026 update, the FDA reported another recall affecting about 35,880 boxes because of contamination with a diluted propylene glycol-based coolant from a packaging machine. Class I designations imply a reasonable probability that exposure to a violative product could cause serious adverse health outcomes. The recalls underscore FDA risk assessments and the ongoing vigilance around OTC products. Propylene glycol carries known toxicity risks at high doses, including effects on the central nervous system and metabolic disturbances. Haleon said ingestion of contaminated SoftGels may cause nausea, vomiting, abdominal pain and diarrhea, though no consumer reports had been received at press time. The agency also notes labeling and manufacturing controls remain critical to prevent such contamination. These events illustrate how an OTC drug can trigger extensive regulatory action when quality-control lapses occur.