Number of FDA Drug Recalls on the Rise – and No One Knows Why

2014 may prove a (dubious) record year for FDA drug recalls. The number of FDA drug recalls has risen each year, multiplying seven times over from 166 in 2004 to 1,225 last year. With nearly 840 already announced this year, 2014 is on track for an all-time record number of medications removed from the market. In fact, FDA data shows that the last 24 months have seen almost as many recalls (2,061) as the previous nine years combined (2,217).

While the sheer numbers are troubling enough, what’s more concerning is that the nation’s health officials are unsure what’s pushing the continual surge. Pharmaceutical and medical device manufacturers often have to recall drugs, devices and food products for an array of reasons, which can range from simple and relatively innocuous labeling mistakes to serious, potentially life-threatening issues. Common recall prompts include including improper labeling, packaging defects, contamination, improper testing or a product’s inherent safety and the potential that its use could cause harm to a patient or user.
Drug recalls are issued in three separate classes:

• Class 1: A product undoubtedly will cause serious ill effect, including possible death, in a user.
• Class II: A product has been known to cause an adverse, but reversible health effect.
• Class III: A product is unlikely to cause adverse health consequences, but is being recalled simply for safety’s sake.

Class II recalls make up about 70 percent of the total drug recalls, followed by Class 1 at 21 percent and Class III at 9 percent. Experts believe that one factor in the latest surge may be the fungal meningitis outbreak of 2012, which killed more than 60 people. In response, the FDA quickly initiated a crackdown on compounding pharmacies, noting that a large percentage of Class II recalls were related to issue with these pharmacies, including their provision of products that had possible, but unconfirmed microbial contamination.

Another factor may be continual efforts to improve current good manufacturing practices (cGMP). A single manufacturing plant found to be deficient in any one cGMP can lead to dozens, or even hundreds of recalls of its multiple products. Whatever the reason, a rise in the number of FDA drug recalls is certainly a matter of concern. If you or your loved one has suffered adverse health consequences after using a recalled drug or device, you may be due fair compensation. Talk with a doctor immediately to assure your health issue is treated, then call 800-251-1111 and speak with a product liability or dangerous drugs and medical products attorney with Jacksonville’s Harrell and Harrell.