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Results for “levothyroxine”
Drug facts and side effects, recalls, research, clinical trials and medical reference, from the FDA, the National Library of Medicine and this site.
Drug lookup
Levothyroxine Sodium
- Not on the FDA shortage list
- 18 recalls in the last 3 years
Boxed warning
WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including levothyroxine sodium tablets, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
What it is used for
Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
How it comes
Levothyroxine sodium tablets USP are round, colored, scored and debossed with following debossing details on one side and break-line on other side. They are available as follows (Table 4) Table 4: Levothyroxine Sodium Tablet Strengths and Identifying Features Tablet Strength Tablet Color/Shape...
Recalls in the last 3 years
-
Oct. 28, 2026
Drug recall, ongoing
Levothyroxine Sodium (2 products)
Pfizer, sold nationwide
Why: Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
Sept. 23, 2026
Drug recall, ongoing
Thyroid
Vitruvias Therapeutics, sold nationwide
Why: Superpotent Drug
Class I: could cause serious harm or death
About 1.2 million people in the US are prescribed thyroid each year.
The FDA record, with lot numbers (opens in a new tab) -
Sept. 2, 2026
Drug recall, ongoing
Levothyroxine Sodium (12 products)
Accord Healthcare, sold nationwide
Why: Subpotent Drug
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
July 29, 2026
Drug recall, ongoing
Levothyroxine Sodium (12 products)
Major Pharmaceuticals, sold nationwide
Why: Subpotent Drug
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
July 8, 2026
Drug recall, ongoing
Levothyroxine Sodium
Accord Healthcare, sold nationwide
Why: Subpotent Drug
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
April 1, 2026
Drug recall, ongoing
Levothyroxine Sodium
Macleods Pharma USA, sold nationwide
Why: Subpotent Drug
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
Jan. 21, 2026
Drug recall, ongoing
Levothyroxine Sodium Tablets
Alvogen, sold nationwide
Why: Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
Oct. 15, 2025
Drug recall, ongoing
Levothyroxine Sodium
Accord Healthcare, sold nationwide
Why: Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
Aug. 20, 2025
Drug recall, ongoing
Levothyroxine Sodium
Pfizer
Why: Subpotent drug
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
July 23, 2025
Drug recall, ongoing
Levothyroxine Sodium (7 products)
Accord Healthcare, sold nationwide
Why: Subpotent Drug: Assay below the approved specification
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
June 18, 2025
Drug recall, ongoing
Levothyroxine Sodium
Macleods Pharmaceuticals, sold nationwide
Why: Presence of a foreign substance: black hair found embedded in tablet.
Class III: unlikely to cause harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
May 7, 2025
Drug recall, ongoing
Levothyroxine Sodium (4 products)
Accord Healthcare, sold nationwide
Why: Subpotent
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
March 26, 2025
Drug recall, ongoing
Levothyroxine Sodium (2 products)
Mylan Institutional, sold nationwide
Why: Super-Potent Drug: Out of specification potency results were obtained.
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
Jan. 8, 2025
Drug recall, terminated
Levothyroxine Sodium
Lupin Pharmaceuticals
Why: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
Dec. 18, 2024
Drug recall, ongoing
Levothyroxine Sodium (6 products)
Mylan Institutional, sold nationwide
Why: Subpotent and Superpotent Drug
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
Dec. 18, 2024
Drug recall, ongoing
Levothyroxine Sodium Tablets USP (11 products)
Viatris, sold nationwide
Why: Superpotent Drug and Subpotent Drug: potency failures obtained
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
Dec. 11, 2024
Drug recall, terminated
Levothyroxine Sodium
Accord Healthcare, sold nationwide
Why: Subpotent drug
Class II: could cause temporary or reversible harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab) -
Nov. 15, 2023
Drug recall, ongoing
Levothyroxine Sodium
Abbvie
Why: Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
Class III: unlikely to cause harm
About 19 million people in the US are prescribed levothyroxine each year.
The FDA record, with lot numbers (opens in a new tab)
Full prescribing information (DailyMed) (opens in a new tab) Patient information (MedlinePlus) (opens in a new tab)
From the FDA drug label and openFDA records. For reference, not medical advice.
Most-reported side effects
304,552 reports to the FDA
- Fatigue25,707
- Nausea21,994
- Drug ineffective21,014
- Headache18,850
- Diarrhoea18,265
- Dyspnoea16,340
- Pain16,168
- Dizziness15,281
- Off label use13,301
- Arthralgia13,081
From the FDA Adverse Event Reporting System. These are voluntary reports: they do not show that the drug caused the event, or how often it happens.
Research
59,027 articles in PubMed, most relevant first
Optimal Thyroid Hormone Replacement (opens in a new tab)
Jonklaas J
ETA guidelines for the use of levothyroxine sodium preparations in monotherapy to optimize the treatment of hypothyroidism (opens in a new tab)
Centanni M, Duntas L, Feldt-Rasmussen U, et al.
Hypothyroidism in Context: Where We've Been and Where We're Going (opens in a new tab)
Chiovato L, Magri F, Carlé A
Challenges in the treatment of hypothyroidism: malabsorption and pseudo-malabsorption of levothyroxine (opens in a new tab)
Mana DL, Rizzo LFL
Effect of oral semaglutide on the pharmacokinetics of thyroxine after dosing of levothyroxine and the influence of co-administered tablets on the pharmacokinetics of oral semaglutide in healthy subjects: an open-label, one-sequence crossover, single-center, multiple-dose, two-part trial (opens in a new tab)
Hauge C, Breitschaft A, Hartoft-Nielsen ML, et al.
Over- and Undertreatment With Levothyroxine (opens in a new tab)
Alaeddin N, Jongejan RMS, Stingl JC, et al.
Clinical trials
769 studies on ClinicalTrials.gov
Comparison of the Effect of Gluten-Free-Lactose-Free / Aronia Melanocarpa Supplemented Diet in Patients With Hashimoto's Thyroiditis (opens in a new tab)
Halic University
Thyroid Function in Late Preterm Infants (opens in a new tab)
Christiana Care Health Services
Effect of Metformin on Decrement in Levothyroxin Dose Required for Thyroid Stimulating Hormone (TSH) Suppression in Patients With Differentiated Thyroid Cancer (opens in a new tab)
Mashhad University of Medical Sciences
The Relationship Between Serum rT3 Concentrations, T3/T4 Ratio, and Symptoms/Quality of Life in Treated Hypothyroid Patients (opens in a new tab)
Semmelweis University
Thyroid Function Tests and Status of Thyroid Autoantibodies in Covid-19 Patients (opens in a new tab)
Bezmialem Vakif University
Theophylline Treatment for Pseudohypoparathyroidism - Children 2-12 Years Old (opens in a new tab)
Vanderbilt University Medical Center
Medical reference
StatPearls, for clinicians
Thyroid Disease and Pregnancy (opens in a new tab)
Levothyroxine (opens in a new tab)
Physiology, Thyroid Hormone (opens in a new tab)
Subclinical Hypothyroidism (opens in a new tab)
See all 313 StatPearls chapters (opens in a new tab)
MedlinePlus, for patients
Thyroid Diseases (opens in a new tab)
Your thyroid is a small, butterfly-shaped gland in the front of your neck. It makes hormones that control the way the body uses energy. These hormones affect nearly every organ in your body and control many of your...
Hyperthyroidism (opens in a new tab)
What is hyperthyroidism? Hyperthyroidism, or overactive thyroid, happens when your thyroid gland makes more thyroid hormones than your body needs. Your thyroid is a small, butterfly-shaped gland in the front of your...
Hypothyroidism (opens in a new tab)
What is hypothyroidism? Hypothyroidism, or underactive thyroid, happens when your thyroid gland doesn't make enough thyroid hormones to meet your body's needs. Your thyroid is a small, butterfly-shaped gland in the front...
Research, trials and reference come from the National Library of Medicine (PubMed, ClinicalTrials.gov, StatPearls on the NCBI Bookshelf, MedlinePlus); drug facts, side-effect reports and recalls from the FDA. For reference, not medical advice.