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# Drug Recalls Down, Units Up
- URL: https://www.fdaweb.com/drug-recalls-down-units-up/
- Published: 2019-08-13T12:00:00.000Z
- Updated: 2026-09-15T01:43:37.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5144751

Drug recalls decreased 18.1% to 77 in the second quarter of 2019, tied for the second lowest number over the past 10 quarters, according to the Stericycle Quarter 2 recall index. However, the [report](http://www.fdaweb.com/download.php?file=ExpertSolutions-RecallIndex-Q22019-WEB.pdf) says that recalled units increased 86.3% to just under 24 million, almost double the number of recalled units in the first quarter of this year.

Stericycle says the average number of recalls per quarter so far in 2019 is down 9% from the average in 2018, while the average number of recalled units per quarter is down 76% from the average in 2017 and 2018.

Some 14.3 % of recalls were Class 1, 66.2% were Class 2, and 18.2% were Class 3\. The report says that 79.2% of drug recalls were nationwide. There were just under 23 million Class 2 units recalled in the second quarter, higher than 13 of the previous 15 quarters.

CGMP deviation was the top reason for drug recalls for the first time since at least the first quarter of 2016\. It also was the top reason for drug recalled units, and has been the top cause for units for four of the last five quarters.

The average size of a recall was 311,560 units, higher than 11 of the previous 15 quarters.

Medical device recalls increased 22% to 200, lower than nine of the previous 12 quarters. Recalled units decreased 85.4% to 19.7 million, the lowest since the first quarter of 2017\. The average number of recalls per quarter in 2019 is down 32.1% from the average quarter in 2017 and 2018, while the average number of units per quarter in 2019 is down 29.9% from the average in 2018.

The average medical device recall size was 98,662, making this the lowest quarter since the first quarter in 2017\. Quality issues (52.3%) were the top cause based on units for the second consecutive quarter. Before the first quarter this year, the last time quality issues were the top cause was Quarter 3 of 2016\. Some 56% of the recalls were of products distributed domestically and internationally. That is the highest percentage since 2016 Quarter 1.