According to a report from the Regulatory Affairs Professionals Society, if the number of drug recalls continues at its current rate, 2014 could bring in the highest number of recalls to date.
Leading the way are Class II recalls. As defined by the FDA a Class II Recall is “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The FDA reports 836 recalls as of mid-August 2014, 650 of which are Class 2. In 2013 there were 1,225 recalls of which 84% were Class II. The increase in recalls has been steady in all Classes but Class II has seen the most significant growth. The 2012 stats show 76% of the 499 recalls were in Class II.
The growth in these recall reports can be attributed mainly to compounding pharmacies. Many of those pharmacies had products which had possible—but unconfirmed—microbial contamination.