A nationwide recall has been issued for a type of thyroid medication over potency issues, according to a notice published by the Food and Drug Administration (FDA) this week.
The recalled medication is levothyroxine sodium and includes tablets in different counts and different strengths, the notice said. The FDA said it was recalled because it’s a “subpotent drug,” without elaborating.
Major Pharmaceuticals, an Ohio-based company, issued the recall on July 13. The FDA labeled the action as a Class II recall on July 17, said the notice, which was published to the FDA’s recall database this week.
A Class II recall is described by the federal drug regulator as “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Levothyroxine sodium, which is sold under multiple brand names, is used to treat hypothyroidism, where the body’s thyroid gland does not produce enough hormones. It can also be used to decrease the size of enlarged thyroids, according to the Mayo Clinic, as well as treating a form of thyroid cancer.
The drug is one of the most prescribed in the United States—No. 3 in terms of prescriptions and patients—according to drug database ClinCalc. More than 80 million estimated prescriptions were filled out for the medication in 2023, with more than 18 million patients, the site says.
List of Recalled Medications
Several lots of the levothyroxine sodium are in 100-count cartons in 10-by-10 blister packs, distributed by Major Pharmaceuticals, including the following:
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25 mcg (0.025 mg) — NDC: 0904-6949-61 | Lot: N02212 (Exp. 07/2026)
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50 mcg (0.050 mg) — NDC: 0904-6950-61 | Lot: N02200 (Exp. 10/2026)
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75 mcg (0.075 mg) — NDC: 0904-6951-61 | Lots: N02172 (Exp. 07/2026); N02296, N02288 (Exp. 12/2026)
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88 mcg (0.088 mg) — NDC: 0904-6952-61 | Lot: N02310 (Exp. 01/2027)
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112 mcg (0.112 mg) — NDC: 0904-6954-61 | Lot: N02203 (Exp. 09/2026)
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125 mcg (0.125 mg) — NDC: 0904-6955-61 | Lot: N02266 (Exp. 11/2026)
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150 mcg (0.150 mg) — NDC: 0904-6956-61 | Lot: N02167 (Exp. 07/2026)
And 10-count cartons that were distributed by Major Pharmaceuticals and Ohio-based Cardinal Health, including the following:
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25 mcg (0.025 mg) — Carton/Bag NDC: 55154-3558-0 | Blister NDC: 0904-6949-61 | Bag Lots: N02212A, N02212B (Exp. 07/2026) | Blister Lot: N02212 (Exp. 07/2026)
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50 mcg (0.050 mg) — Carton/Bag NDC: 55154-3559-0 | Blister NDC: 0904-6950-61 | Bag Lots: N02200A, N02200B (Exp. 10/2026) | Blister Lot: N02200 (Exp. 10/2026)
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75 mcg (0.075 mg) — Carton/Bag NDC: 55154-3560-0 | Blister NDC: 0904-6951-61 | Bag Lots: N02172A, N02172B (Exp. 07/2026), N02288A, N02288B (Exp. 12/2026) | Blister Lots: N02172 (Exp. 07/2026), N02288 (Exp. 12/2026)
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125 mcg (0.125 mg) — Carton/Bag NDC: 55154-3562-0 | Blister NDC: 0904-6951-61 | Bag Lots: N02266A, N02266B (Exp. 11/2026) | Blister Lot: N02266 (Exp. 11/2026)
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150 mcg (0.150 mg) — Carton/Bag NDC: 55154-3563-0 | Blister NDC: 0904-6956-61 | Bag Lot: N02167A (Exp. 07/2026) | Blister Lot: N02167 (Exp. 07/2026)
The recalling company did not provide a news release for the recall and did not provide other information to consumers, including whether a refund is available.
The notice also did not say how many packages of the medication are impacted.