Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns

Regulatory NewsRegulatory News | 11 August 2014 |  By 

Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month.


Pharmaceutical companies occasionally need to recall—that is to say, remove—products from the market. While the reasons for product recalls vary, they are commonly related to packaging defects, contamination of a product, improper testing of a product, or inherent safety problems which could lead a product to harm a patient.

Those recalls are classified according to a three-tier system administered by FDA:

  • Class I Recall - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
  • Class II Recall - 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.
  • Class III Recall - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

FDA—not the companies—classify recalls. When a product is recalled by a company, it must submit to FDA various information, including the name of its product, its National Drug Code (NDC), its approval number, lot/unit number, its strength and route of administration, the extent of the recall, and a reason for the recall. That last should, according to FDA's Guidance for Industry: Product Recalls, Including Removals and Corrections, include a detailed explanation of how the product is either defective or violative, how it affects the safety of the product, the nature of the defect and any information on how users should protect themselves in the meantime.

Recalls Surging

But while FDA has overseen recalls for decades, the agency has recently been seeing an unprecedented surge in the number of recalls reported to the agency.

FDA Drug Recalls by Year and Classification
YearTotal RecallsClass IClass IIClass III

*Year as of 11 August 2014

As FDA data show, the last two years have seen almost as many recalls (2,061) as the previous nine years combined (2,217)—and that's only counting the first seven months of 2014.

But perhaps the most interesting trend in the data is not the surge in reported recalls, but instead what is driving that increase.

Class II Leads the Charge

The overwhelming majority of the increase in recalls is being driven by a surge in Class II recalls, for which "use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences."

FDA Recall Classifications by Allocation

YearTotal RecallsClass IClass IIClass III

*Year as of 11 August 2014

As shown in the above graph, despite a brief surge in 2006, when Class II recalls constituted 94% of all recalls, Class I recalls have consistently hovered around 50% of all recalls classified by FDA.

But in 2012, 2013 and 2014, Class II recalls have become the norm, constituting 76%, 84% and 77% of all recalls, respectively. That surge has come even as Class III recalls have remained relatively consistent (as a total number) over the course of the last decade.

While Class I recalls have also increased, they have remained within the confines of historical norms as well, and are actually lower now than they were during the 2009-2011 period.

Why the Rise?

It's difficult to blame any one factor for the rise in recalls, but one trend may be to blame for a sizeable portion of it. Beginning in 2012, FDA initiated a crackdown on compounding pharmacies after a massive and deadly outbreak of fungal meningitis which killed more than 60 people.

An inspection of recall reports by Regulatory Focus indicates that a sizeable number of Class II recall reports were related to compounding pharmacies. Many of those pharmacies had products which had possible—but unconfirmed—microbial contamination.

Other Class II recalls seen by Focus were for current good manufacturing practice (cGMP) deficiencies, which can often affect dozens of products at one time, with each generating its own recall notice. A single manufacturing plant experiencing cGMP deficiencies can result in dozens, if not hundreds of recalls.

It's also worth noting that not all recalls are created equal. Under FDA's recall classification scheme, a recall of 100,000 drug products is treated the same as a recall notice for just one dialysis bag. And because many compounding pharmacy recalls are for just a small handful of products, it's possible that even with a large surge in the number of recalls, the total amountof product recalled could be relatively consistent.

But with 2014 already on pace for a record-breaking year for recalls, perhaps it's worth asking if this is an anomalous, one-time surge in recalls, or if the rise is the new normal for the foreseeable future.


Data Obtained From


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