Thyroid medication described as ‘subpotent drug’ recalled by FDA

As a Class II recall, the FDA warned that the thyroid drug could cause “temporary or medically reversible adverse health consequences.”

WASHINGTON — A commonly prescribed thyroid medication has been recalled, according to the U.S. Food and Drug Administration.

The levothyroxine sodium tablets—used to treat hypothyroidism, cancer and Hashimoto’s disease, among other conditions—had apparently been functioning as a “subpotent drug,” meaning the drug has less of an active ingredient and was therefore less effective. 

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The recalled drugs were all packaged and distributed by Major Pharmaceuticals, with some further distributed by Cardinal Health.

As a Class II recall, the FDA warned the thyroid drug could cause “temporary or medically reversible adverse health consequences.” The recall was initiated on July 13. 

Alexa Cimino, 27, said levothyroxine had become a lifeline after losing her thyroid to cancer in 2024. For Cimino, news of the recall has been terrifying. 

“Every morning, I have to trust that what’s in that bottle is exactly what my doctors prescribed. When you’ve survived thyroid cancer, taking levothyroxine isn’t a choice — it’s a daily act of trust,” Cimino said on Monday. “The thought that a dose might not be as strong as it’s supposed to be is genuinely horrifying. You build your life around believing that medication is protecting you, and a recall like this shakes that trust in a way that’s hard to describe.” 

Dr. Abeer Hassoun, a pediatric endocrinologist at Columbia University Medical Center, called the medication “the bread and butter” of her patients’ treatment plans. Many who suffer from congenital hypothyroidism begin taking the drug as newborns with the tablets crushed up. Any change in dosage, Hassoun noted, would affect the brain development of younger patients. 

“They will walk later,” Hassoun said on Monday. “It can affect their growth and cognitive ability.” 

Hassoun noted that patients who have been behind on their medication have demonstrated poor, “sluggish” performance in school.

However, Hassoun said that regardless of the dosage on the package, she and other endocrinologists will always test patients to ensure they are receiving the correct amount of the drug.

“How suboptimal are they saying? If they’re talking about what we’re using now. It’s effective,” Hassoun said. “Some of them might need to be given more, and some of them might need less … it’s not very concerning as long as I follow the patients.” 

The tricky part for patients, however, Hassoun notes, would be accessing other, typically more expensive, name-brand medications if the recall impacts patients’ insurance coverage of levothyroxine. 

“It’s cheaper than the brand-name Synthroid,” Hassoun said of levothyroxine sodium tablets. “If the insurance doesn’t cover it, it will be more difficult. I have to say it will be troublesome to manage.”

Twelve different dosages and cartons were listed on the FDA recall, which also went into detail on the lot numbers and expiration dates.

The tablets were distributed nationwide, but the FDA notice did not specify how many tablets in circulation were recalled.

Levothyroxine sodium tablets impacted by the recall:

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61 | Lot#: N02212 | Expiration date: July 2026Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61 Lot#: N02200 | Expiration date: October 2026Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61Lot# N02172 | Expiration date: July 2026; N02296, N02288 | Expiration date: December 2026Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61Lot #: N02310 | Expiration date: January 2027Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61Lot #: N02203 | Expiration date September 2026Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61Lot #: N02266 | Expiration date: November 2026Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61Lot #: N02167 | Expiration date: July 2026Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61Bag lot#: N02212A, N02212B | Expiration date: July 2026; Blister lot #: N02212, | Expiration date: July 2026Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61Bag lot #: N02200A, N02200B | Expiration date: October 2026; Blister lot #: N02200 | Expiration date October 2026Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61Bag lot #: N02172A, N02172B | Expiration date: July 2026; N02288A, N02288B, Expiration date: December 2026; Blister lot #: N02172, Expiration date: July 2026; N02288, Expiration date: December 2026Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61Bag lot #: N02266A, N02266B, Expiration date: November 2026; Blister lot #: N02266, Expiration date: November 2026Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61Bag lot #: N02167A, Expiration date: July 2026; Blister lot # N02167, Expiration date: July 2026

Editor’s note: This story initially included a product image of YARAL Pharma’s levothyroxine medication, which is not a part of this recall. The story has been updated to remove that image.