The FDA uses the following definitions for prescription drug recalls.
Class I recall
A situation in which there is a reasonable probability that use of, or exposure to, a product will cause serious adverse health consequences or death.
Class II recall
A situation in which the use of or exposure to a product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Sharp Health Plan promptly identifies and notifies affected members and their prescribing physicians when we are notified of a Class I or Class II drug recall. Notification is sent to members who have received their medication using the Sharp Health Plan
outpatient pharmacy benefit.
Visit FDA.gov to learn about recent drug recalls, market withdrawals and safety alerts.Learn more