U.S. pharmaceutical recall activity rose in 2025 alongside broader increases in product safety actions across multiple sectors, according to Sedgwick’s 2026 State of the Nation U.S. Product Safety and Recall Index. The report recorded 3,295 recalls across the five major industries Sedgwick tracks—pharmaceuticals, medical devices, food and beverage, consumer products, and automotive—marking a modest year-over-year increase from 2024. Defective units, however, climbed sharply to 858 million, up 26% from the prior year.
Within life sciences, both the pharmaceutical and medical device sectors saw higher volumes of recalls and defective units compared with 2024, underscoring the growing complexity of global supply chains, post-market surveillance expectations, and manufacturing quality demands.
Sedgwick’s analysis links the trend to shifting federal oversight and policy changes under the Trump Administration, which emphasized encouraging domestic manufacturing while reconfiguring regulatory priorities. Despite efforts to reduce certain regulatory burdens, FDA and other agencies reinforced expectations around adverse event reporting, manufacturing documentation, and timely notification of product defects. Several companies faced substantial penalties for delayed recall actions.
“Regulators across industries are looking to increase oversight, improve the effectiveness of product recalls, and expand post-market responsibilities beyond just the manufacturer,” said Chris Harvey, Senior Vice President at Sedgwick.
Looking ahead, Sedgwick anticipates that heightened monitoring, transparency requirements, and pressure on pharmaceutical pricing will continue to shape recall activity and compliance strategies throughout 2026.
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