The total number of U.S. products recalled this year has now topped 1 billion, according to our latest U.S. product Recall Index. More than 1 billion units have been recalled only twice before in history, in 2018 and 2021. However, it took a full year to reach the benchmark during those years, while it has only took the first seven months of 2022 — making this the year likely to experience record-breaking product recalls by number of units.
Legislators and regulators alike have tightened their inspection of every sector of the economy, enacted new standards and directives, and begun publicly naming businesses they deem to be non-compliant. The automotive, food and drink, consumer products, pharmaceutical and medical device industries continually face new risks that are getting harder to resolve due to persistent public health concerns, geopolitical issues, and other factors.
In this most recent index report, we analyze recall data from the second quarter of 2022 and look ahead at Q3 data from July. To assist you in understanding and preparing for the issues your industry may encounter in the second half of 2022, we have also provided insights and forecasts from several of our key partners at leading law firms in the U.S.
NHTSA releases additional safety guidelines as automotive recalls rise
The National Highway Traffic Safety Administration (NHTSA) had a busy second quarter, announcing a number of fuel efficiency requirements and boosting civil penalties, which could soon subject the automotive industry to millions of dollars in fines. NHTSA will continue to focus on autonomous vehicles (AV’s); the organization is preparing to revise safety regulations that may increase the burden of compliance for automakers, but will boost customer confidence in AV’s. Following two consecutive quarters of decline, the number of automotive recall occurrences jumped in Q2 2022 to 245. 9.21 million units were impacted, which was consistent with the prior quarter (with 9.25 million).
Children’s safety continues to be the CPSC’s top priority
As we have seen for several quarters, children's safety continues to be a top focus for the Consumer Product Safety Commission (CPSC). Chemicals known as per- and polyfluoroalkyl substances (PFAS) are quickly moving to the top of the list of dangerous substances that should be the subject of legislation and legal action. Inconsistent regulation at the state and federal level are introducing additional risks for companies. Consumer product recalls dropped from 77 in Q1 2022 to 65 in Q2 2022, a 15.6% decline. In Q2, there were a total of 6.7 million units recalled, a reduction of only 3.5% from the previous quarter.
Infant formula shortage has lasting impact
The U.S. Food and Drug Administration (FDA) and other regulatory agencies continue to investigate the reasons for the infant formula shortage in early 2022, as well as the FDA’s slow response times and prevention measures. The hazards for food importers will increase as the FDA is anticipated to start enforcing the Foreign Supplier Verification Programs (FSVP) severely with the goal of increasing security and transparency in the food supply.
There were 120 food and drink recall events recorded by the FDA in Q2 2022, an increase of 9.1% from Q1. The number of units impacted, however, fell sharply (81.3%) to 27.5 million units. With 13 events, the number of food recalls by the U.S. Department of Agriculture (USDA) in Q2 2022 reached its highest level in more than two years. In addition, the number of units affected significantly increased by 1,391% to 973,374 pounds.
Cybersecurity emerging as a key concern in the medical device industry
The FDA is releasing advice to safeguard medical devices against cyberattacks to keep up with advancements in medical device technology. With the heightened risk to patients’ safety in the case of a cybersecurity incident involving medical devices, the FDA will likely continue to focus on this area. Lawmakers are also attempting to improve public health emergency preparedness, including changes that might have an impact on the medical device sector. The number of impacted units decreased 96.8% to their lowest level in ten years, while the number of medical device recall events rose 34.0% to a two-year high, with 268.
The FDA exercises enforcement role for pharmaceutical industry
With the FDA recently sending warning letters for cannabis-infused products and prohibiting the sale of an e-cigarette company's products, the pharmaceutical industry can expect to face additional enforcement activity. Despite the prohibition being lifted, it's likely that the problem will still persist. The FDA has since made attempts to start a prohibition on flavors other than tobacco, including menthol in cigars and cigarettes. A total of 94 pharmaceutical recall events occurred for the second consecutive quarter. At 20.6 million units in Q2, the number of affected units decreased to its lowest level in more than a year.
Over 1 billion units of vehicles, food and drink, drugs, consumer products, and medical devices have been impacted by product recalls for the second year in a row. If the first half of the year is any indication, 2022 should surpass all other years on record with regard to the number of recalled products. Despite these daunting numbers, companies must not let up on their commitment to product safety, even while regulatory bodies may be returning to pre-pandemic operations. Inspections and enforcement actions will continue to take place.
In the face of these obstacles, businesses should continuously evaluate and update their product recall, crisis and communication plans to ensure their brands and reputations will overcome whatever new challenges arise.
Download a full copy of the recall index report, and get the full picture on the latest data, insights, trends, and predictions impacting product safety and regulation in your industry here.