Major Pharmaceuticals has recalled multiple lots of levothyroxine sodium tablets nationwide after routine testing found the pills did not contain the full dose printed on the package, and the FDA classified the recall as Class II on July 17, according to the agency’s enforcement report. The recall covers 12 products in seven strengths, from 25 to 150 micrograms, and patients are being told to keep taking their medication.
Key takeaways
- Routine stability testing found the tablets were subpotent. Twelve products are affected, and some lots do not expire until January 2027.
- The FDA says lasting harm is unlikely and advises patients to keep taking their medication rather than stop.
- Pharmacies are not required to call you, so you have to check your own lot number.
What happened
Major Pharmaceuticals told its wholesale customers in a letter dated July 10 that the recall began “due to out of specification results obtained during routine stability testing for Assay,” according to a copy of the letter shared with Healthline. The assay measures how much active drug a tablet actually holds.
The tablets were manufactured by Lupin Pharmaceuticals and distributed by Major Pharmaceuticals and Cardinal Health, per the packaging labels included in that letter. AARP reports the affected expiration dates run from July 2026 to January 2027.
A Class II recall means “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences,” or that “the probability of serious adverse health consequences is remote,” an FDA spokesperson told Healthline. The recall is being run at the retail level, so pharmacies are told to pull stock from their shelves but are not required to contact patients.
This has happened before. The FDA documented 10 levothyroxine recalls for subpotency, content uniformity, and stability between 1990 and 1997, before the drug required formal approval. More recently, Accord Healthcare recalled 82,159 bottles of 25 mcg levothyroxine tablets in June 2025, also a Class II subpotency recall.
Dr. Kumar’s take
“Not likely to cause adverse health effects” is a statement about the average patient. I can name the patients for whom it is not true.
Pregnancy is the clearest one. Thyroid hormone requirements rise early in pregnancy, and under-replacement in the first trimester matters for fetal brain development. A pregnant patient on a subpotent lot should not wait and watch.
Older patients with heart disease are second, and the danger runs both ways. If the potency drop pushes them hypothyroid, the strain on the heart is real. But the correction can be worse than the problem, because replacing too fast in a patient with coronary disease can trigger chest pain or an arrhythmia.
Third are thyroid cancer patients kept on deliberately high doses to suppress TSH after surgery. For them the dose is not replacement, it is cancer treatment, and a weaker tablet undoes the point of it.
A modest potency drop matters at all because levothyroxine has a narrow therapeutic index. Small changes in the blood level produce real symptoms, and those symptoms are vague: creeping fatigue, feeling cold, dry skin, constipation, low mood, a few pounds gained. Patients read that as getting older. Doctors read it as depression or stress. Nobody thinks about the pill.
One timing detail no wire story mentions: levothyroxine takes about six weeks to reach a steady level in the blood. A TSH drawn two weeks after switching lots tells you almost nothing, and a normal early result can falsely reassure you.
The other side of this is that stability testing caught the problem before anyone was hurt, which is the system working. And for some people the better question is whether they need the drug at all, since some older adults can stop levothyroxine entirely without their thyroid numbers worsening.
What it means for you
Do not stop your medication. The FDA is explicit that stopping a recalled drug can cause more harm than continuing it.
Because most pharmacies pour tablets into their own vials, the lot number will not be on your bottle. Call the pharmacy that filled your last prescription and ask for the manufacturer, the NDC number, and the lot number on file, then compare them against the recall list.
If you are pregnant, have heart disease, or are on TSH suppression for thyroid cancer, call your prescriber this week rather than waiting for your next scheduled visit. Everyone else on an affected lot should ask for a TSH check about six weeks after starting a new bottle.
Photograph the label when you refill. It is the fastest way to answer this question the next time a lot gets recalled, and the history of drug supply and pricing problems says there will be a next time.