The FDA is recalling some of the medication that as many as 22 million Americans are taking annually.
Major Rugby aka Major Pharmaceuticals, one of the largest companies making generic medications in the US, is recalling a number of levothyroxine sodium tablets, expiring between this month and early next 2027.
The company says the reason is the medication was found to be “subpotent,” that is, it may not be strong enough to work effectively. The FDA classified this as Class II, which means it could cause temporary health consequences.
List of recalled medications
Levothyroxine comes in liquid filled capsules, solutions and tablets. Tablets from the brands “Major” and “Cardinal” are being recalled.
Major brand
- 25 mcg, 100 tablets, Lot # N02212, expiration 7/2026
- 50 mcg, 100 tablets, Lot # N02200, expiration 10/2026
- 75 mcg, 100 tablets, Lot # N02172, N02296, N02288, expiration 07/2026 and 12/2026
- 88 mcg, 100 tablets, Lot # N02310, expiration 01/2027
- 112 mcg, 100 tablets, Lot # N02203, expiration 09/2026
- 125 mcg, 100 tablets, Lot # N02266, expiration 11/2026
- 150 mcg, 100 tablets, Lot # N02167, expiration 7/2026
Cardinal brand
- 25 mcg 10 tablets, Lot # N02212A, N02212B (bag), N02212 (blister), expiration 7/2026
- 50 mcg, 10 tablets, Lot # N02200A, N02200B (bag), N02200 (blister), expiration 10/2026
- 75 mcg, 10 tablets, Lot # N02172A, N02172B, N02288A, N02288B (bags), N02172, N02288 (blister), expiration 07/2026 and 12/2026
- 125 mcg, 10 tablets, Lot # N02266A, N02266B (bags), N02266 (blister), expiration 11/2026
- 150 mcg, 10 tablets, Lot # N02167A (bag), N02167 (blister), expiration 07/2026
To check whether your medicine is affected, compare the lot numbers.
The company asked that distributors tell their customers to return the product.
Experts recommend calling their doctor if you find your medication is affected by the recall. They will help you get replacement tablets, rather than forcing you to suddenly stop taking the medication or adjust the dose yourself.
About the drug
Levothyroxine is used to treat hypothyroidism, which is when the thyroid doesn’t produce enough thyroid hormone.
As many as 12% of Americans (about 40 million) have hypothyroidism. Because the gland is responsible for your metabolism and energy, hypothyroidism can appear as unintentional weight gain and exhaustion.
It may also appear as constipation, coarse hair and skin, muscle weakness and tenderness, thinning hair, depression, and memory problems. The thyroid is also responsible for temperature control, so people affected might be more sensitive to cold.
Hypothyroidism is often mistaken for other conditions, like depression, or menopause or aging. But if it’s left untreated, it can cause serious conditions like heart disease and nerve pain.
Levothyroxine is also used to shrink swollen thyroid glands, or “goiters.” These can also appear if hypothyroidism is left untreated. The thyroid gland swells in size as it tries to make more of the hormone, which can cause discomfort and trouble swallowing.
The medication works by replacing the thyroid hormone the body is having trouble naturally producing.
Levothyroxine is also used to treat thyoid cancer in combination with surgery and radioiodine treatment.
Just last year, 160,000 bottles of the drug were recalled from North Carolina-based Accord Healthcare’s India-based manufacturer. In 2023, IBSA Pharma recalled an oral solution of Levothyroxine.
Both of these recalls were also due to subpotency.
