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Press Release

A Bitter Pill: Recalled Pharmaceutical Units Increase 444 Percent in Q2

Stericycle ExpertSOLUTIONS
Posted on: 10 Aug 17

INDIANAPOLIS, Aug. 8, 2017 /PRNewswire/ -- Pharmaceutical recall activity saw a disturbing rise not only in the volume of products recalled last quarter, but also in the severity of risk to consumers, according to the latest Recall Index released today by Stericycle ExpertSOLUTIONS (NASDAQ: SRCL).

More than a hair out of place

Pharmaceutical recalls increased 6 percent over the previous quarter to 86. More jarring, the volume of recalled drug units circulating in homes and store shelves climbed 444 percent over the previous quarter, making it the most active quarter since Q4 2014.

Most concerning was the number of recalls for Class I situations, safety issues that pose the highest risk of serious adverse consequences or death, according to the Food and Drug Administration (FDA). There were 11.6 million Class I pharmaceutical units recalled in Q2, making it the highest since at least 2004. Superpotency, where a pharmaceutical might contain more than the listed amount of an active ingredient, was not a major cause of Class I recalls, but it was the top cause for Class I units.

"The number of Class I units recalled in Q2 increased nearly 45 thousand times over the previous quarter. That is a tough pill to swallow," said Michael Good, Vice President of Marketing & Sales Operations, Stericycle ExpertSOLUTIONS. "The top cause of these recalls was, of all things, a foreign material like hair. This spike in both high-risk and overall recall activity should be a red flag for the industry."

When head of the class isn't a good thing

The trend in Class I recall activity affected several other vertical markets as well, including medical devices and food & beverage:

Class I recalls in medical devices were up 88 percent largely caused by a quality issue, such as a part or section of the device that may detach or malfunction in a particularly dangerous way.

FDA Class I food recalled units were up 340 percent with the top cause being bacterial contamination from salmonella.

USDA Class I food recalls were up 86 percent, while USDA Class I food recalled units were up 561 percent. The top cause for both recalls and recalled units was undeclared allergen, mostly milk.

"Class I is the most critical type of recall, so to see increases across multiple industries where serious adverse consequences or death can occur is certainly concerning," continued Good. "Having a recall management strategy in place so you can act quickly and efficiently when the inevitable occurs is more important than ever when the recall is designated a Class I."

Remaining recall results

Consumer product recalls declined just 2 percent from Q1 2017 to Q2, down to 64, while recalled units declined 64 percent to about 3.4 million, the lowest since Q4 2012. In automotive, recalls decreased 11 percent to 187 – the lowest quarter since Q1 2015. Recalled automotive units dropped 58 percent to about 5.4 million – the second lowest quarter since Q1 2013.

The full Q2 2017 Recall Index and video are available at

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 ExpertSOLUTIONS™
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 ExpertSOLUTIONS™ is the industry leader in managing automotive, consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertSOLUTIONS streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for leading global companies. For more information, visit

Editor's Details

Mike Wood

Last updated on: 10/08/2017

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