Thyroid medicine recalled nationwide: FDA - The Hill

What the report says

The Hill reported that Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets across the United States after federal regulators said the product was subpotent, meaning it may not deliver its full intended effect. According to the report, the Food and Drug Administration announced the recall this month, and the action was initiated July 13.

The FDA classified the recall as Class II on July 17, a category used when exposure to a product could cause temporary or medically reversible health problems, or when the likelihood of serious harm is considered remote. The Hill reported that Major Pharmaceuticals packaged and distributed the recalled tablets nationwide, while Cardinal Health distributed some of the affected product.

The recalled medicine was packaged in 10-count blister packs, either sold separately or in cartons containing 10 packs, for a total of 100 tablets. The affected strengths listed by the FDA were 25, 50, 75, 88, 112 and 150 micrograms, with expiration dates ranging from July 2026 through January 2027. The agency did not state how many tablets were included in the recall, according to The Hill.

Levothyroxine is commonly prescribed for hypothyroidism and may also be used for goiter and other thyroid-related conditions, as The Hill noted, citing Mayo Clinic information. Because thyroid hormone dosing can be clinically important, patients who believe they have affected tablets should consult a pharmacist, prescriber or the FDA recall notice for product-specific guidance rather than stopping or changing medication on their own.