Which type of recall requires drugs to be retrieved from patients?

A Class I recall is considered the most serious type of recall issued by the FDA and is required when there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. This type of recall necessitates that the product be retrieved from patients who have already obtained it, as patients may be at significant risk if they continue to use the affected medication.

In the case of a Class I recall, manufacturers and pharmacies are mandated to notify patients and ensure the return of the medication to protect public health. This is in contrast to other types of recalls, which may not carry the same level of urgency or health risk associated with them. For instance, Class II recalls involve situations that may cause temporary or medically reversible health consequences, while Class III recalls are related to products that are unlikely to cause any adverse health issues. Voluntary recalls can occur at any level but may not always involve direct patient retrieval unless the situation falls into the more serious categories, such as a Class I recall.