Why do products get recalled by the FDA


This week the FDA announced a recall of the popular Metformin tablet from Time-Cap Labs, Inc. used to treat type 2 diabetes. These tablets are amongst many products recalled by the FDA in the past month. Heavily used products ranging from cosmetics, foods to actual drugs are frequently recalled by the FDA, so why do these products get recalled and what is the process in getting these products off the shelves?

Recalled products are products that are defective or potentially harmful to consumers and the FDA raises concern with these products for the well-being of the public. Believe it or not, most recalls are made on a voluntary basis by companies if it’s not a FDA-regulated product. Sometimes companies discover a defect or a potential problem with a product and recall it on their own. Rarely does the FDA issue a request for a recall of a product. The FDA’s role in recalls is to assist companies in raising awareness and promotion in recalls of products.

What are FDA-Regulated products?

There is a great divide on what is FDA-regulated and what is not. Some cosmetics are FDA regulated if they contain color additives while cosmetics that refrain from color additives are not regulated by the FDA. The following is a clarification of what is FDA-regulated and would receive a recall directly from the FDA:

  • human drugs
  • animal drugs
  • medical devices
  • radiation-emitting products
  • vaccines
  • blood and blood products
  • transplantable human tissue
  • animal feed
  • cosmetics (with color additives)
  • about 80 percent of the foods consumed in the United States

When does the FDA get involved in non-FDA-Regulated products:

The FDA becomes involved in product recalls in a couple of ways. The first being from a voluntary proposition made by companies that have suspected a defect or a potential problem. The FDA frequently conducts manufacturing facility checks and if there is an issue within the check they could propose a potential recall of products produced in the facility. Health problem reports and reports from the CDC (Center for Disease Control and Prevention) go hand and hand with the FDA’s involvement. If the FDA receives numerous reports from various health reporting systems or the CDC contacts them about an illness potentially brought on by a specific product on the market they will raise concern for the recall.

Classifications of recalls:

When a product is recalled there are different ways to classify the recall.

A class I recall means the product is dangerous or defective and could cause serious health problems or death. Some examples of this is food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve, or cancerous toxins like the recent Metformin tablet recall.

A class II recall means products might cause a temporary health problem, or pose only a slight threat of a serious nature. An example of this is a drug that is under-strength but that is not used to treat life-threatening situations.

A class III recall are products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Some examples are minor container defects and lack of English labeling in retail food or cosmetics.

How do recalled products re-enter the market?

Before a recalled product is put back on the shelves and is made available again it needs to go through quality and effectiveness checks. First, the FDA examines whether all efforts have been made to remove or correct a product by a company. Recalls are considered complete after all of the company’s corrective actions are reviewed by the FDA and are seen as appropriate coinciding with the classification of the recall. After a recall is finalized or completed, the FDA makes sure that the product is destroyed or suitably reconditioned, and investigates why the product was defective in the first place. In some cases, some products do not re-enter the market.

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