For full functionality of this page it is necessary to enable JavaScript. Here are the instructions how to enable JavaScript in your web browser A Bitter Pill: Recalled Pharmaceutical Units Increase 444 Percent in Q2

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

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 Q2 2017 Recall Index.

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 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 racecalled 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.

Meanwhile, 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

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