Major Pharmaceuticals initiated a voluntary recall of its levothyroxine sodium tablets on July 13 after the Food and Drug Administration determined the pills were subpotent, meaning they deliver less medication than labeled.
The recall covers 12 levothyroxine sodium tablet packages distributed under the Major and Cardinal brand names since January 2025
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Major Pharmaceuticals initiated a voluntary recall of its levothyroxine sodium tablets on July 13 after the Food and Drug Administration determined the pills were subpotent, meaning they deliver less medication than labeled.
The FDA assigned the recall a Class II designation on July 17, a classification that signals the tablets could produce temporary negative health effects. According to the FDA, Major Pharmaceuticals was responsible for packaging and distributing the medication across the country, with Cardinal Health $CAH handling distribution for part of the supply.
Levothyroxine sodium is used to treat hypothyroidism, enlarged thyroid glands, and a type of thyroid cancer, according to the Mayo Clinic.
The recall covers 12 package configurations sold under the Major and Cardinal brand names, according to USA Today. Each package contains either a single 10-tablet blister pack or a carton bundling 10 such packs together for a total of 100 tablets. The recalled tablets span dosage strengths of 25, 50, 75, 88, 112, 125, and 150 micrograms, and their expiration dates fall between July 2026 and January 2027. All recalled packages require a prescription.
In a letter sent to retailers earlier this month, Major Rugby — the pharmaceutical manufacturer behind the products — said taking the recalled medication "is not likely to cause adverse health effects," according to USA Today. The company nonetheless urged consumers to return the tablets to their point of purchase and consult a doctor if they find any affected product.
Distribution of the recalled tablets began in January 2025. The FDA declined to provide a total tablet count for the recall.
Consumers can identify recalled packages by checking the lot numbers listed in the FDA recall notice. Among the affected lots are packages of 25 mcg (lot N02212), 50 mcg (lot N02200), 75 mcg (lots N02172, N02296, and N02288), 88 mcg (lot N02310), 112 mcg (lot N02203), 125 mcg (lot N02266), and 150 mcg (lot N02167).
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