An FDA recall is one of the most terrifying things that can happen to a company that makes a medical device or drug. It represents the kind of negative publicity that can destroy a brand, cripple sales and ruin a company for decades. How an FDA recall happens is an important part of your business planning process, because it tells you what you can do, when designing your product, to avoid a recall in the future.


There are several things you should know about the FDA recall process :

• The statutory limits of what the FDA can and cannot do on a recall
• Most recalls done are voluntary recalls; most are food related
• The types of recalls that the FDA handles

All of these factors interrelate when a product recall happens.


Statutory Limits

First, the FDA’s role in the recall process is often misrepresented in both the consumer advocacy and mainstream business press. When the newspapers report “650,000 cases of peanut butter recalled”, they imply that the FDA can order a full recall. This isn’t precisely the case – the 1938 Federal Food, Drug and Cosmetic Act gave the FDA some enforcement capabilities such as injunction and seizure, but not the power to require a company to perform a recall. However, the bureaucratic machinery needed to use those enforcement powers would actually take longer to use than we see in the real world cases of product recalls. Therefore FDA recommends that a company recall a product and if the company does not comply, then FDA can seize the product and take additional action against the company and it’s officers.

What usually happens is that the FDA requests a recall, with the implication that if the manufacturer (or distributor) does not comply, they’ll be prosecuted under the amended 1938 act mentioned above. The FDA can order a recall only under unusual circumstances. These include, but are not limited to, infant formula recalls, medical tissue product recalls (such as skin graft cultures) and medical device recalls where there’s a significant risk to a patient if the device is not used in its mandated and recommended way.


Voluntary Recalls

The vast majority of product recalls are voluntary; the FDA notifies the manufacturer of a problem that needs to be addressed, and the manufacturer (and distributor) announces a product recall. The vast majority of product recalls are for food items, and nearly all of them are related to either salmonella or e coli found at the manufacturing site, with the recalled items being removed before anyone gets sick.

From a manufacturer's perspective, the public relations harm of having a recall is much lower than the public relations harm of having newspapers linking your product with a widespread e coli outbreak, as happened with some spinach from California in 2008.

While the FDA and news media refer to these as voluntary recalls, the reality is that failing to recall the product opens the manufacturer up to a strong litigation case that will very likely cost more than the recall does, including a court mandated recall that is not voluntary.


Types of FDA Recalls

In general, there are three types of FDA recalls. In decreasing severity, they run from Type I recalls, which could cause serious health problems. Food with botulotoxin or undeclared allergens or a label mix-up on a drug are examples of Type I recalls.

Type II recalls are less severe than Type I; rather than running the risk of death, they are for products that can cause temporary health problems or a slight risk of a serious complication. The classic example of this is a mislabeled drug that's understrength, but not used in life threatening situations.

A Type III recall is the lowest severity recall – it's usually a recall for instances where a product's use won't cause an adverse health reaction, but may violate packaging or labeling restrictions. Examples might be a plastic container that delaminates, or a misprinted label, leaks in a bottled drink, or strange tastes and colors in a large batch of products.

After a recall has been placed, manufacturers and distributors are expected to keep the FDA informed about the progress of the recall. Once it's complied with, the FDA monitors the destruction and disposal of the recalled product.

The final result of a recall process is an interesting blend of cooperation and coercion; the recall system in place that's cooperative between the agency and manufacturers is the fastest one in the developed world, and the FDA calls on manufacturers to work out contingency plans (and provides resources to help these plans come into fruition and make them work in ways that are mutually beneficial.) Most of the notifications about a product recall are handled by the companies performing the recall; the FDA only gets into the notification cycle when the product presents a clear and present danger.

We encourage you to call us at 248 747 8008 or email Regulatory Affairs Associates at info@regaffairs.net if you have to organize your company or product response in a recall situation. We have handled many of these before and will save you time, money and worry.