Patients taking levothyroxine are being advised to check their medicine packaging after multiple strengths and lots were included in a nationwide recall.
Multiple lots of levothyroxine sodium tablets, one of the most commonly prescribed thyroid medicines in the United States, have been recalled nationwide because they may contain less active medication than intended.
Major Pharmaceuticals initiated the recall on July 13, 2026, and the US Food and Drug Administration classified it as a Class II recall on July 17.
The affected tablets were described as subpotent, meaning they may deliver a lower dose of levothyroxine than stated on the label. For patients who rely on the medicine every day, reduced potency could lead to inadequate control of thyroid hormone levels.
Advertisement
Low-Potency Tablets Trigger a Nationwide Recall
The recall covers selected levothyroxine strengths packaged in 100-tablet cartons and 10-tablet blister packs distributed by Major Pharmaceuticals and Cardinal Health.
A Class II recall means that using the affected product may cause temporary or medically reversible health problems, while the likelihood of severe consequences is considered remote.
The FDA notice did not specify how far below the required potency the tablets were or how many packages were distributed.(2✔ ✔Trusted Source
Often-Prescribed Thyroid Drug Recalled Across the US
Advertisement
Why Levothyroxine Is Important for Hypothyroidism
Levothyroxine is a synthetic form of thyroxine, one of the main hormones normally produced by the thyroid gland.
It is primarily prescribed for hypothyroidism, a condition in which the thyroid does not produce enough hormones to support normal metabolism and body functions.(1✔ ✔Trusted Source
Hypothyroidism
Go to source) It may also be used for certain enlarged thyroid conditions and as part of treatment for some thyroid cancers.
Symptoms of poorly controlled hypothyroidism may include:
- Persistent tiredness
- Weight gain
- Feeling unusually cold
- Dry skin or hair loss
- Constipation
- Muscle weakness
- Slower heart rate
- Difficulty concentrating
- Depression or low mood
Because levothyroxine has a narrow therapeutic range, even relatively small changes in the amount absorbed can affect thyroid-stimulating hormone and thyroid hormone levels.
Advertisement
Review the Package Before Your Next Dose
The recalled 100-tablet cartons include:
- 25 micrograms: N02212
- 50 micrograms: N02200
- 75 micrograms: N02172, N02296 and N02288
- 88 micrograms: N02310
- 112 micrograms: N02203
- 125 micrograms: N02266
- 150 micrograms: N02167
The recall also covers certain 10-tablet blister packs containing:
- 25 micrograms: N02212A and N02212B
- 50 micrograms: N02200A and N02200B
- 75 micrograms: N02172A, N02172B, N02288A and N02288B
- 125 micrograms: N02266A and N02266B
- 150 micrograms: N02167A
Expiration dates range from July 2026 to January 2027, depending on the strength and lot.
Patients should compare the strength, National Drug Code, lot number and expiration date on their packaging with the official recall information.
Do Not Stop Thyroid Treatment Suddenly
Anyone who has an affected product should contact a pharmacist or healthcare provider for guidance on obtaining a replacement.
Patients should not stop taking levothyroxine without medical advice. Suddenly interrupting treatment may allow hypothyroidism symptoms to return or worsen, particularly in pregnant women, older adults and people with heart disease.(2✔ ✔Trusted Source
Often-Prescribed Thyroid Drug Recalled Across the US
A healthcare professional may recommend replacing the medicine and checking thyroid blood tests if there is concern that a patient has received an inadequate dose.
Patients who experience worsening fatigue, swelling, unusual weight gain, marked cold intolerance, confusion or other significant symptoms should seek medical advice promptly.
References:
- Hypothyroidism- (https://medlineplus.gov/hypothyroidism.html)
- Often-Prescribed Thyroid Drug Recalled Across the US- (https://www.prevention.com/health/a73246480/thyroid-levothyroxine-sodium-recall-fda/)
Source-Medindia