How Serious Is This Recall?
The FDA has classified this as a Class II recall—which means it represents “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.”
In plain terms: this is a precautionary action, not an emergency. The FDA is not suggesting that people who took this medication are in immediate danger. The concern is about long-term exposure above acceptable limits—not a single dose or short-term use.
