U.S. product recalls have surpassed 1 billion units in 2026, driven largely by a sharp increase in pharmaceutical and medical-device recall volumes, according to Sedgwick’s latest U.S. Product Safety and Recall Index.
Regulators recorded 941.2 million recalled units during the first half of 2026, up 345.5% from 211.2 million units in the first half of 2025. The six-month total also exceeded the full-year 2025 figure, Sedgwick said.
With July data included, recalled products surpassed 1 billion units for the year, marking only the fourth time in the past 15 years that annual U.S. recall volume has crossed that threshold. The number of recall events, however, remained largely unchanged: 1,634 events in the first half of 2026 compared with 1,636 in the year-earlier period.
Pharmaceutical recalls accounted for 471.6 million units in the first half, a 914% increase from a year earlier. Medical-device recalls totaled 313.1 million units, rising 516.8% year over year. Together, the two sectors represented more than four-fifths of all recalled units recorded through June.
The pharmaceutical sector had already posted a 12-year quarterly high in the first quarter, when 218.8 million units were recalled. Sedgwick said that total was largely driven by one recall involving antiseptic towelettes, hand sanitizer and other products containing benzalkonium chloride.
Food recalls also rose substantially. USDA food-recall volume increased 2,432.1% to 37.2 million pounds during the first half, Sedgwick said, making the period the third-highest annualized food-recall volume recorded in more than 15 years.
Chris Harvey, Sedgwick’s senior vice president for product innovation and industry engagement, said the data show that stable recall-event counts do not equate to stable business exposure.
“Today’s risk environment is defined less by how often recalls occur and more by the scale and complexity of those that do,” Harvey said. He said a single large recall can materially increase operational, financial and reputational risk.
Sedgwick said companies also face uncertainty from geopolitical developments, tariffs and changes in trading relationships. Regulators have increased attention to consumer-recall fraud, country-of-origin claims and food chemical safety, while automotive companies face new restrictions affecting certain imports and air-bag inflators.
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