Product Units in Recalls Surge 346% in the H1 2025 as Regulatory Scrutiny Intensifies

The number of overall recall events held roughly steady in the first half of 2026, but the volume of affected units increased during the same period and is on pace to exceed 1 billion units in 2026, according to Sedgwick’s Product Safety and Recall Index.

The report tracked 1,634 recalls in the first half across the automotive, consumer products, food and drink, pharmaceutical, and medical device sectors, compared with 1,636 in H1 2025. In fact, four of the five sectors tracked by Sedgwick saw event counts decline year over year, with consumer products the lone exception.

But the story of H1 2026 was volume: all sectors except food governed by the Food and Drug Administration had more recalled units than in H1 2025. At midyear, there were 941.2 million units affected by recalls, a volume that has already surpassed the full-year 2025 total for units recalled, the report found. Pharmaceutical and medical device units impacted by a recall each rose more than 500%, while food governed by the U.S. Department of Agriculture’s recall volume climbed nearly 2,500%.

Sedgwick’s report also pointed to a shifting regulatory backdrop shaping the recall environment, including continued disruption from the conflict with Iran, new tariffs, and evolving trade relationships. The USDA and Federal Trade Commission tightened enforcement of country-of-origin claims for U.S.-made goods, while the FDA moved to modernize inspection procedures for medical devices and pharmaceuticals.

The automotive sector is also contending with new restrictions on hardware and software imports from China and other foreign adversaries, a ban on certain non-U.S. air bag inflators, and the lack of a renewed U.S.–Mexico–Canada Agreement, which now requires the three countries to negotiate trade terms annually, according to the report.

Consumer Products And Automotive Diverge On Volume

The consumer products sector logged 289 Consumer Product Safety Commission recalls in H1 2026, up 37.6% from 210 in H1 2025 and the highest half-year total in 29 years, Sedgwick reported. Units recalled rose 60.4% to 27.03 million, from 16.85 million a year earlier.

Yard & Garden led all consumer products categories with 48 recalls, up from 18 in H1 2025 and the category’s highest half-year total in more than a decade, driven in volume by two grill brush recalls totaling 13.40 million units.

Ingestion was the top hazard by event, linked to 46 recalls compared with just five in H1 2025, with 60.9% tied to coin and button cell batteries and 30.4% tied to magnets.

Automotive recalls, by contrast, fell to a six-year low, with the National Highway Transportation Safety Administration issuing 431 recalls in H1 2026, down 6.5% from 461 in H1 2025. Yet impacted units surged 111.6% to 23.48 million, a five-year high for the sector, from 11.09 million.

Electrical systems remained the leading automotive recall cause by event, with 74 recalls, though that was down from 93 in H1 2025 and 104 in H1 2024. Electrical systems also topped the volume rankings at 6.23 million units, a 10-year high, including a single recall of 4.38 million vehicles tied to a trailer communication fault that could cause loss of braking and signal functions while towing.

Pharmaceutical And Medical Device Volumes Hit Multiyear Highs

FDA pharmaceutical recalls dipped slightly to 177 in H1 2026 from 184 in H1 2025, but units recalled jumped 914.0% to 471.64 million, the sector’s highest level in 18 years, from 46.51 million, according to Sedgwick. Current Good Manufacturing Practice deviations drove the most volume, at 214.35 million units, largely from a single recall of products containing Benzalkonium Chloride.

Class I pharmaceutical recalls fell to a five-year low of 14 events, yet volume climbed from 1.05 million units in H1 2025 to 174.52 million in H1 2026, the sector’s highest Class I volume in more than 20 years.

FDA medical device recalls declined 5.1% to 461 in H1, from 487 events in H1 2025, while impacted units rose 516.8% to 313.07 million, a five-year high, from 50.75 million. Sterility was the leading cause by volume, with 179.45 million units, including two convenience kit recalls totaling 172.33 million units.

Meanwhile, USDA food recalls fell 62.5% to nine events in the first half from 24 events a year ago, but pounds affected rose 2,432.1% to 37.18 million, the highest H1 level in a decade, largely tied to a single chicken fried rice recall involving foreign material that affected 36.99 million pounds.

Obtain the full report here. &