recall classes (class I, II, III)
the FDA's severity scale for drug recalls: class I means reasonable probability of serious harm or death; most recalls are routine class II quality issues.
a headline saying a drug 'was recalled' tells you almost nothing until you know the class and the scope.
the scale
Class I: reasonable probability of serious injury or death. Class II: temporary or reversible harm, or serious harm remote. Class III: unlikely to cause harm — labeling and quality violations. Across the psychiatric drugs in this library, recalls are overwhelmingly Class II and III, and our record pages report 'no Class I recall' as a verified negative, checked against the openFDA enforcement database on a stated date.
severity and scope are different axes
The single Class I in the library: one capsule of a potentially lethal heart drug found in a sealed bottle of Effexor XR in 2014 — severe enough for the top classification, narrow enough to be one bottle. A good recall report states both axes; ours quote the enforcement record verbatim.
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questions
has my antidepressant been recalled?
Probably in some Class II/III quality action at some point — most drugs have been. Our record pages state each drug's full recall count and classes from the openFDA database.
what was the Class I psychiatric drug recall?
Effexor XR, March 2014: a Tikosyn (dofetilide) capsule found in a sealed bottle — recalled at the top classification with deliberately narrow scope.
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more from the glossary
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