Allergic Reaction: Allergens Cause Dangerous Spike in FDA Recalled Food Units in Q3

Tuesday, November 7, 2017 Drug News
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Stericycle Expert Solutions' Q3 2017 U.S. Recall Index shows significant increase in health- and life-threatening Class I recall activity largely due to undeclared allergens found in food products

INDIANAPOLIS, Nov. 7, 2017 /PRNewswire/ -- Recalled FDA food units increased 19 percent to 106.6 million in the third

quarter of 2017 – higher than 20 of the last 22 quarters – and public health risks rose sharply due to a spike in undeclared food allergens found in food products, according to the Q3 2017 Recall Index from Stericycle Expert Solutions (NASDAQ: SRCL).

The Recall Index, which reports quarterly on recalls in the food, pharmaceutical, automotive, medical device, and consumer product industries, found that FDA food recalls declined 11 percent in Q3 2017 to 158 recalls. While that would usually be seen as good news, the scale and severity of the recalls were troubling.

Of the FDA recalled food units in Q3, 95.6 percent were considered Class I threats – the most serious health-threatening classification. Nearly all (96.9 percent) of the recalled units were because of undeclared allergens, which have been a consistent cause of all food recalls (38.9 percent) for the last four quarters. The top allergens from Q3 2016 through Q3 2017 were milk, followed by nuts, soy, and wheat. The number of pounds of food recalled by the USDA dropped (by 27 percent) but allergens accounted for 62.5 percent of recalls.

"Allergens continue to be a leading cause of food recall activity, and manufacturers still struggle to find a solution," said Mike Good, Vice President of Marketing & Sales Operations, Stericycle Expert Solutions. "It is a growing concern because as the number of allergen-caused recalls have increased, so has the number of people with food allergies in the U.S. The Center for Disease Control (CDC) estimated that 4 to 6 percent of children and 4 percent of adults now suffer from food allergies, causing approximately 30,000 emergency room treatments and 150 deaths each year."

Consumer Products and Med Device Recalls Down; Auto and Pharma Recalls Slightly IncreaseThe Recall Index found positive and negative trends across the other categories as well. Consumer product recalls dropped 8 percent to 59 – the lowest number since Q1 2015. At the same time, incidents reported to the Consumer Product Safety Commission plummeted 92 percent to 895, while injuries decreased 62.3 percent to 114. 

Sports and recreational equipment made up the top recall category for the sixth quarter in a row with 23 recalls. Volume-wise, home furnishings and fixtures were the most pervasive, making up 76.2 percent of all recalled units. While incidents and injuries declined, the top peril was entrapment, strangulation, or lacerations, comprising 76.1 percent of all recalled consumer product units.

The medical device industry also saw a decline in recalls, dropping 39 percent to 167 – the lowest quarter since Q4 2011. Despite this steep drop, recalled units ticked up 1 percent to 68 million. The main reason was sterility issues, causing 89.4 percent of all medical device recalled units. Software issues were the biggest cause of recalls at 24.6 percent, making it the top recall cause for the sixth quarter in a row.

The Q3 2017 Recall Index found that pharmaceutical recalls ticked up 3 percent to 89 – the highest since Q4 2014. More significantly, the number of recalled drug units spiked 290 percent, the highest total of any quarter since Q1 2012. The chief cause was sterility problems, which accounted for 96.7 percent of all recalled units, largely from one pharmaceutical manufacturer.

National Highway Traffic Safety Administration (NHTSA) automotive recalls climbed slightly by 5 percent to 197, marking the second consecutive quarter with fewer than 200 recalls, which last occurred in Q4 2013 and Q1 2014. The slight increase in recalls is due to an 85x spike of electrical system recalled units in the third quarter, up from just under 19,000 units in Q2 to more than 1.6 million in Q3.

The full Q3 2017 Recall Index is available for download:

About the Stericycle Recall Index The Stericycle Recall Index is the only report that aggregates and tracks recall data to help manufacturers and other industry stakeholders navigate the regulatory environment and identify trends. Each quarter Stericycle analyzes data from the U.S. Consumer Product Safety Commission (CPSC), the National Highway Traffic Safety Administration (NHTSA), the FDA, and the USDA. For more information, please visit

About Stericycle Expert Solutions™Stericycle Inc. is a NASDAQ-listed global business-to-business services company which provides highly specialized solutions to healthcare and commercial businesses of all sizes. Founded in 1989, Stericycle Inc. has grown to become a leader across a range of complex and highly regulated market sectors and operates in 550 locations. Stericycle Expert Solutions is the industry leader in managing automotive, consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. Expert Solutions streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for leading global companies. For more information, visit

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SOURCE Stericycle Expert Solutions


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