Classes of Recalls: From Class I Salmonella Recall, to Allergens, to Packaging Defects
The Food and Drug Agency (FDA) oversees the safety of products ranging from imported bananas to pharmaceutical drugs. The Agency strives to ensure only safe and effective products reach the market by preventing unsafe products from entering the market. The FDA is also responsible for overseeing recalls.
Sometimes, a product is deemed unsafe after already entering the market. When a product regulated by the FDA is either defective, contaminated, mislabeled, or potentially harmful, the FDA issues a recall on the product. Some of the recalls are more pressing than others, however, and there are three classes of recalls dependent on level of hazard involved.
Class I recalls are for products that could seriously affect someone’s health (think Class I Salmonella Recall, for example). An recent example was a recent class I salmonella recall on ground beef recently. In fact, most recalls due to bacteria, such as those issued due to salmonella, e.coli, listeria, or campylobacter, are Class I recalls.
Class II recalls are less severe and are for products that might pose only temporary health problems.
Class III recalls are mostly for products violating the FDA’s labeling/manufacturing laws.
The FDA obtains necessary information about a product’s safety through various mediums including:
- Contact from a company to the Agency
- FDA Inspections
- Reporting services. Follow this link to access the MedWatch Voluntary Reporting Form’s information page: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
- Contact from the Center of Disease Control
For information about teh most recent Class I salmonella recalls, or recalls in general, the media (like the news and Twitter) is effective, but you can also look up recalls on the FDA’s “Enforcement Reports” (follow the link here https://www.fda.gov/safety/recalls/enforcementreports/default.htm)
The five formal actions of FDA enforcement include the following:
- Administrative detentions and seizures of product
- Recalls (based on level hazard)
- Import refusal and alerts
- Restraining order and injunctions
- Suspension of facility registration[1]
[1] “Food Law and Regulation for Non-Lawyers: a US Perspective.” Food Law and Regulation for Non-Lawyers: a US Perspective, by Marc C. Sanchez, Springer, 2015, pp. 31–67.
