The FDA has classified a nationwide levothyroxine recall involving select Major Pharmaceuticals tablets after potency testing found some lots contained less active ingredient than required. The action covers multiple strengths and package sizes used for thyroid treatment.

Nationwide levothyroxine recall

The U.S. Food and Drug Administration has classified a nationwide recall involving select lots of levothyroxine sodium tablets distributed by Major Pharmaceuticals after the products were found to be subpotent. Levothyroxine is a prescription thyroid hormone used mainly to treat hypothyroidism and may also be prescribed to reduce an enlarged thyroid gland, commonly called a goiter.

A subpotent medication contains less active ingredient than required, which may reduce its intended therapeutic effect. The recall applies only to identified lots and package configurations, not every levothyroxine prescription sold in the United States.

Strengths and packages affected

The recall covers 12 product entries across seven strengths: 25, 50, 75, 88, 112, 125 and 150 micrograms. The affected medication was supplied in 100-tablet cartons and 10-tablet blister packs.

Patients should compare the strength, lot number and expiration date on their medication with the FDA enforcement listing. A pharmacist can also confirm whether a prescription was filled using an affected lot.

FDA assigns Class II status

Major Pharmaceuticals initiated the recall on Monday, July 13, 2026. The FDA classified the action as a Class II recall on Friday, July 17, 2026.

Under the FDA system, a Class II recall means use of a product may cause temporary health consequences, while the probability of a serious health issue is considered remote. The recalled tablets were distributed nationwide, and available enforcement information did not specify how many tablets entered the market.

What patients should do

Anyone who believes they have an affected product should contact a pharmacist or prescribing clinician for instructions. Patients should not stop taking levothyroxine or change their dosage without medical guidance. The FDA advises that people affected by Class II recalls can generally continue taking their medicine unless the company or agency provides different instructions.

The recall remains limited to the listed lots. Pharmacies and patients will need to verify package information while affected inventory is identified and removed from distribution.