On March 9, 1938, physicians recorded what is now cited as the earliest documented instance of a commercially marketed pediatric preparation causing clear harm because of its ingredients. The case involved a child who exhibited severe toxicity after receiving a widely available children’s remedy that, by contemporary standards, contained unsafe substances. Though specifics of individual product names and full clinical records may not be complete in surviving public archives, the incident is tied to a broader pattern in the early 20th century: limited regulation, variable labeling, and insufficient safety testing of medicines intended for children. Context: early-20th-century pediatric remedies In the decades leading up to 1938, many households relied on over-the-counter mixtures for coughs, colds, teething, and other common childhood ailments. These preparations often combined sedatives, alcohol, opiates, or other potent compounds with flavorings to make them palatable for children. Regulatory oversight varied by country, and standardized toxicology testing and pediatric dosing guidelines were still developing. As a result, formulations that posed risks to infants and young children circulated widely. The 1938 incident Medical reports from the period describe a child who developed acute symptoms consistent with poisoning after administration of an advertised pediatric elixir. Symptoms noted in contemporary clinical descriptions included central nervous system depression, respiratory difficulty, and altered consciousness—findings compatible with exposure to sedative or narcotic agents that were present in some pediatric remedies of the era. Treating physicians recognized the association between the product and the presentation and documented the case, contributing to growing concern among clinicians and public health officials. Impact and legacy Though this March 1938 case alone did not immediately transform regulation, it became part of an accumulating body of evidence that medicines marketed for children needed stricter oversight. Over ensuing years, public health authorities, medical associations, and consumer advocates pressed for clearer labeling, restrictions on certain compounds (notably opiates and high concentrations of alcohol), and age-appropriate dosing directions. These efforts helped shape later reforms in pharmaceutical manufacturing standards, labeling laws, and the development of pediatric pharmacology as a specialty. Limitations and historical uncertainty Surviving documentation from 1938 is fragmentary. Precise identification of the brand or exact formulation implicated in this specific case is not consistently preserved in the public record, and some contemporary accounts use generic terms like “children’s tincture” or “pediatric elixir.” Scholarly histories of drug regulation and period medical journals corroborate that harmful pediatric preparations were a recognized problem in this era, but attributing systemic change to any single case risks overstating the evidence. Where details are uncertain or disputed, historians rely on multiple contemporaneous reports and later regulatory records to reconstruct the pattern of harm and reform. Why this matters today The March 9, 1938 case is a reminder that medical products for vulnerable populations have long required careful testing, transparent labeling, and regulatory oversight. It underscores the historical roots of modern safety standards in pediatric medicine and the role clinicians and families played in identifying hazards. Contemporary systems for drug approval, pharmacovigilance, and child-specific dosing evolved in part from lessons learned during the early 20th century, when well-intentioned remedies sometimes posed unrecognized risks.