PlainMeds guide, sources read October 8, 2026

FDA drug recalls explained

The FDA sorts drug recalls into three classes by how likely the product is to harm someone. Since January 2024 its Enforcement Report lists 1,259 recall entries naming medicines on PlainMeds: 65 Class I, 1,052 Class II and 140 Class III.

What do the three recall classes mean?

FDA, Recalls Background and Definitions
Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall: 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.
Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

The FDA also lists market withdrawals, for minor problems that would not be subject to FDA legal action. A recall almost always names particular products and lot numbers, not every product of a medicine: the record on each medicine page lists the company, the product and the reason.

Source: FDA, Recalls Background and Definitions (content current as of March 20, 2026)

How do you check whether a medicine was recalled?

Search the medicine on PlainMeds: its page lists every Enforcement Report entry that names it, newest first, with the class and the reason. Then compare the lot number on your package with the one in the recall; a recall of one maker's lot does not cover the same medicine from another maker. Pharmacies receive recall notices for the lots they hold.

Which medicines were recalled most in the last two years?

Recalls: FDA enforcement reports, 2012 on
Medicine	Brand names	Generic labelers (all forms)	Pharmacy cost	Boxed warning	Shortage	Recalls since 2012
Levothyroxine	Tirosint, Synthroid, Unithroid	36 labelers	$0.0588 per tablet 112 mcg tablet	Yes	No current entry	128
Duloxetine	Drizalma	45 labelers	$0.102 per capsule 30 mg capsule	Yes	No current entry	56
Cinacalcet	Sensipar	16 labelers	$0.411 per tablet 30 mg tablet	No	No current entry	28
Chlorpromazine	none listed	33 labelers	$0.552 per tablet 100 mg tablet	Yes	No current entry	25
Sodium chloride	none listed	14 labelers	$0.0887 per mL 0.9% vial	No	A presentation being discontinued	77
Testosterone	Jatenzo, Xyosted, Kyzatrex	33 labelers	$11.39 per mL 200 mg/mL	No	No current entry	70
Chlorhexidine and isopropyl alcohol	Chloraprep, Prevantics	none listed	n/a	No	No current entry	30
Atomoxetine	Strattera, Atoncy	20 labelers	$0.442 per capsule 40 mg capsule	Yes	No current entry	15
Carvedilol	Coreg	41 labelers	$0.0179 per tablet 6.25 mg tablet	No	No current entry	22
Clindamycin	Cleocin, Clindagel, Xaciato	60 labelers	$0.137 per gram 1% gel	Yes	In shortage	24

Source: FDA Enforcement Report (drug recalls) via openFDA

What next?

Every recent recall
Why medicines are recalled: reasons since 2024