Product Recalls Surge to 881 Events in Q2 2025 While Units Affected Drop 31.5%

All five major industries analyzed saw increased recall activity amid regulatory shifts and AI-driven oversight changes: Sedgwick.
By: | September 15, 2025
recall

Product recalls jumped to 881 events in the second quarter of 2025, the highest quarterly total since early 2024, even as the number of units affected fell by nearly a third to 85.87 million, according to Sedgwick’s quarterly analysis of U.S. product recall activity.

“Even amidst a rapidly changing regulatory landscape and uncertainty around how regulators will operate in the future, product safety remains the focus for federal agencies,” said Chris Harvey, senior vice president of brand protection for Sedgwick. “Businesses will need to evaluate multiple aspects of their supply chains, pricing models, and compliance programs to ensure their operations align with new approaches to oversight and enforcement.”

Rising Recall Frequency Across All Sectors

Every major industry tracked experienced more recalls in Q2 2025 compared to the previous quarter, marking a significant shift in product safety trends, according to Sedgwick’s report. The automotive sector saw recalls climb 14.4% to 246 events, while consumer products surged to 109 recalls—the highest quarterly total since 2008. FDA food recalls rose 12.6% to 143 events, reaching the second-highest quarterly level since late 2019.

Medical devices continued their upward trajectory with 251 recalls, a 6.4% increase that included 36 Class I events—the highest quarterly total for the most serious category in two decades. The pharmaceutical sector rounded out the increases with 97 recalls, up 11.5% from Q1.

Despite the higher frequency, the total units affected dropped significantly across industries in the second quarter, Sedgwick found.

Automotive units nearly doubled to 7.36 million, but this was offset by dramatic decreases in other sectors. FDA food units plummeted 79.6% to 14.32 million, while pharmaceutical units fell 32.4% to 18.77 million. The overall decline suggests companies are catching quality issues earlier, resulting in smaller-scale recalls.

Regulatory Evolution Creates New Compliance Pressures

The Trump Administration’s push to streamline government operations through AI implementation and regulatory reform is reshaping the recall landscape, according to Sedgwick.

Companies face heightened scrutiny even as agencies modernize their approaches. The Consumer Product Safety Commission recorded no fines in Q2, but the Department of Justice pursued settlement deals and penalties for hazardous products.

“With criminal penalties on the rise and agency oversight in flux, consumer product manufacturers must rigorously document safety measures and prepare for aggressive enforcement,” the report’s authors noted.

Trade tensions and national security investigations added another layer of complexity, particularly for automotive, consumer products, and pharmaceutical manufacturers. An emphasis on boosting U.S. manufacturing capabilities signals potential supply chain disruptions that could impact quality control processes, the report noted.

Preparing for AI-Driven Oversight and Shifting Priorities

The integration of artificial intelligence into regulatory processes demands new strategies from manufacturers across all sectors.

“With FDA downsizing and AI-driven oversight accelerating, food and drink manufacturers must stay audit-ready as ingredient and chemical scrutiny intensifies,” Sedgwick advised.

Medical device manufacturers face particular challenges as software concerns became the leading cause of recalls in Q2 with 44 events.

Key risk areas varied by industry but showed clear patterns. Electrical systems dominated automotive recalls with 49 events, while undeclared allergens led FDA food recalls with 62 events—milk being the most common culprit with 18 recalls. For consumer products, falls and burn/fire combinations tied as top hazards with 14 recalls each. Pharmaceutical recalls were driven primarily by manufacturing practice deviations (29 events) and sterility concerns (24 events).

Obtain the full report here. &

The R&I Editorial Team can be reached at [email protected].

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