FDA Recall Classes
The FDA classifies food recalls into three classes: Class I — reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death; Class II — use of or exposure to the product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote; Class III — use of or exposure to the product is not likely to cause adverse health consequences.
Recall Strategy
- ☐ Identify the scope of the recall (lot codes, date codes, distribution area)
- ☐ Notify FDA within 24 hours of initiating a recall
- ☐ Notify all direct customers (distributors, retailers) immediately
- ☐ Issue a press release for Class I and II recalls
- ☐ Post recall information on company website
- ☐ Establish a recall hotline for consumer inquiries
Effectiveness Checks
The FDA requires companies to conduct effectiveness checks to verify that all recalled product has been removed from commerce. Effectiveness checks involve contacting a sample of customers to verify receipt of the recall notice and return/destruction of recalled product. The level of effectiveness checks required depends on the recall class.