Skip to content


Free Consultation

How does the Food and Drug Administration issue a recall?

How does the Food and Drug Administration issue a recall?

Product recalls are a major issue that affects millions of people. They affect issues of personal safety and health and are often the foundations of legal cases. For those reasons, it is important to know basic facts about the Food and Drug Administration’s product recalls.

Why are recalls done?

Recalls are done to protect the public. The FDA determines that a product is defective or for some other reason potentially harmful. If people continued to use that product, they would be endangering their health and safety. So, the FDA issues a recall to let people know why the product is dangerous and to get it out of homes and stores.

How does the FDA become aware of product problems?

One way is the company that produces the product discovers that something is wrong and voluntarily reports the problem to the FDA. Another way is for the FDA to inspect a manufacturing facility and from doing so, comes into possession of information that prompts a recall. The FDA may also receives reports about health problems though a variety of other reporting systems or hear about them directly through the Centers for Disease Control and Prevention.

What categories of recall classifications are there?

There are three. Class I covers products that can cause serious health problems or even death. These can include foods with undeclared allergens, food containing botulinum toxin and a label mix-up on a drug meant to save lives.

Class II recalls are for products that can cause temporary problems or only a modest likelihood of serious problems. Class III recalls are for products that aren’t likely to cause adverse health reactions, but that do violate FDA manufacturing or labeling laws. By understanding these facts, you can be better prepared to deal with any recall that affects you.

Source: Food and Drug Administration, “FDA 101: Product Recalls,” accessed Nov. 17, 2015


“O’Dwyer & Bernstien has helped me in several different situations over the last 12 years that I’ve lived in NYC. They’re my go-to firm because they always obtain the results that I need and deserve. They’re also located in downtown Manhattan, which makes them very convenient. The office and people that work there are exactly what you’d expect from a top tier law firm in the world’s greatest city.”

“When I got hurt in a traffic accident while riding my bike in New York City, my friend suggested I speak to O’Dwyer & Bernstien. Upon my initial phone conversation with a lawyer from the firm I was impressed by his courtesy, quick return phone calls and concise explanation of the legal tactics available to me. After meeting face to face with him, I decided immediately to retain O’Dwyer & Bernstien to represent me in my personal injury case. I was very happy with my attorney and with the outcome of my case. I highly recommend O’Dwyer & Bernstien to anyone seeking legal representation.”

“I retained O’Dwyer & Bernstien on the recommendation of a friend. I was immediately impressed by the firm’s experience and reputation in personal injury law. From the start, my ODB attorney walked me through the process, answered all my questions, explained everything clearly, kept me updated regularly and always promptly returned my telephone calls and emails. My attorney was knowledgeable, professional, courteous and diligent. My case moved through the court system quickly. As trial neared, the insurance company saw that my attorney was experienced and thoroughly prepared to try my case to verdict. As a result, the insurance company caved and settled my case for the full limits of the insurance policy. I love my ODB attorney!”

“When I was hurt on the job I had nowhere to turn for help. I had been working as an electrician’s helper, but my boss was not insured and he had no license to do electrical work. I had just had a new baby girl and Con Ed was going to shut off my lights. A friend told me to call O’Dwyer & Bernstien. They took action right away and got great money for my case. ODB helped me get my life back on track. I will always be grateful.”