The U.S. Food and Drug Administration (FDA) has announced a recall of certain levothyroxine sodium tablets manufactured by Major Pharmaceuticals, also known as Major, and Cardinal. The reason for the recall is that the medication was found to be "subpotent," meaning it may not contain the correct amount of active ingredient to be effective.
The FDA has classified this recall as Class II, indicating that the product may cause temporary adverse health consequences. Levothyroxine is a widely prescribed medication used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. It is estimated that as many as 22 million Americans take this medication annually, and hypothyroidism affects up to 40 million Americans.
This recall affects specific lots of levothyroxine tablets from both the Major and Cardinal brands. For the Major brand, affected products include 25 mcg (Lot # N02212), 50 mcg (Lot # N02200), 75 mcg (Lots # N02172, N02296, N02288), 88 mcg (Lot # N02310), 112 mcg (Lot # N02203), 125 mcg (Lot # N02266), and 150 mcg (Lot # N02167). Expiration dates for these lots range from July 2026 to January 2027.
The Cardinal brand tablets affected include 25 mcg (Lot # N02212A, N02212B, N02212), 50 mcg (Lot # N02200A, N02200B, N02200), 75 mcg (Lots # N02172A, N02172B, N02288A, N02288B, N02172, N02288), 125 mcg (Lot # N02266A, N02266B, N02266), and 150 mcg (Lot # N02167A, N02167). Expiration dates for these lots also range from July 2026 to November 2026.
Patients who have a recalled medication should contact their doctor immediately. Experts recommend consulting a healthcare provider to discuss options for obtaining replacement tablets rather than attempting to adjust dosage or stop taking the medication abruptly. Hypothyroidism can lead to symptoms such as unintentional weight gain, exhaustion, constipation, dry skin, muscle weakness, depression, and cold sensitivity. If left untreated, it can cause serious health issues, including heart disease and nerve pain.
Levothyroxine sodium tablets are crucial for managing hypothyroidism by replacing the hormone the body cannot produce sufficiently. The medication is also used to treat enlarged thyroid glands, known as goiters, and in conjunction with other treatments for thyroid cancer. This is not the first recall for levothyroxine; in the past year, Accord Healthcare and IBSA Pharma have also recalled the drug due to subpotency issues.