Breaking Down the FDA’s 3 Levels of Product Recalls

When the U.S. Food and Drug Administration (FDA) learns that a product or medication is potentially dangerous or violates labeling or manufacturing laws, it will request that the product be recalled by its manufacturer. In some cases, product and medication manufacturers recall items on their own without the FDA’s request, although the FDA will still oversee the company’s recall strategy and assess whether it’s adequate to protect the public.

There are three major types of recalls:

  1. Class I—This type of recall is the most serious and important to pay attention to. Products and medications classified under Class I recalls pose serious health risks to the public, and they can cause severe injuries and even death when used.
  2. Class II—This type of recall is issued when its discovered that products or medications may cause consumers to suffer temporary or minor health problems and injuries, or that they may pose slight threats to the people who use them.
  3. Class III—This type of recall is issued when the FDA’s guidelines concerning labeling and manufacturing aren’t followed. Products subject to Class III recalls rarely pose threats to the general public, but may contain misleading labels or be manufactured improperly.

Companies generally alert the public when their products are subject to Class I or Class II recalls. If they don’t, the FDA will list them on its website. It’s important to check the FDA’s website for recent recalls if you’re prescribed a new medication or purchase an over-the-counter medication.

If you or someone you love gets injured by a defective, dangerous, or recalled product or medication, the drug injury lawyers at Ferrer, Poirot & Wansbrough are here to help. Contact us today for a free consultation.