Levothyroxine is one of the most commonly prescribed medications in the United States. It is used to replace thyroid hormone in people with hypothyroidism, after thyroid surgery, and in some patients with thyroid cancer. The U.S. Food and Drug Administration (FDA) has announced a recall of certain lots of Levothyroxine Sodium Tablets, USP because some tablets may contain a less active ingredient than they should.
The recall applies only to specific lot numbers listed in the FDA enforcement report. If you take levothyroxine, it is important to check whether your medication is included—but do not stop taking it without talking to your healthcare provider.
Why Was the Medication Recalled?
According to the FDA, the recalled tablets are subpotent, meaning they contain less levothyroxine than listed on the label. Because levothyroxine is used to replace a hormone that the body needs every day, receiving a lower dose than prescribed may make the medication less effective.
The recall involves certain strengths of Levothyroxine Sodium Tablets, USP distributed by Major Pharmaceuticals, including several tablet strengths packaged in blister packs and cartons. The FDA enforcement report lists the affected lot numbers and expiration dates.
What Is Levothyroxine Used For?
Levothyroxine is a synthetic form of the thyroid hormone T4. According to the prescribing information, it is approved to:
- Treat hypothyroidism (an underactive thyroid).
- Replace thyroid hormone after thyroid surgery.
- Help suppress thyroid-stimulating hormone (TSH) in certain patients with thyroid cancer.
Because thyroid hormone affects nearly every organ in the body, taking the correct dose is important for normal metabolism, energy levels, heart function, and growth.
What Should Patients Do?
The FDA’s guidance on drug recalls recommends that patients first determine whether their medication is part of the recall before making any changes.
If you take levothyroxine:
- Check the lot number and expiration date on your medication package.
- Compare it with the affected lots listed in the FDA recall notice.
- Contact your pharmacist if you are unsure whether your medication is included.
- Talk with your healthcare provider before stopping or changing your medication.
Do not stop levothyroxine as stopping levothyroxine suddenly may cause your thyroid hormone levels to become too low. Your healthcare provider or pharmacist can help you obtain a replacement if your medication is part of the recall.
Watch for Signs Your Dose May Be Too Low
If you received tablets with less active ingredient than expected, your hypothyroidism may not be fully treated.
Symptoms may include:
- Feeling unusually tired.
- Feeling cold more often.
- Weight gain.
- Dry skin.
- Constipation.
- Trouble concentrating or slowed thinking.
If you notice these symptoms or they become worse, contact your healthcare provider.
What This Means for You
This recall does not affect every levothyroxine prescription. It is limited to specific lots identified by the FDA. If you take levothyroxine, check your medication package, verify whether your lot is included, and speak with your pharmacist or healthcare provider if you have questions. Most importantly, do not stop taking your medication unless your healthcare provider tells you to do so.
Source
U.S. Food and Drug Administration. Levothyroxine Sodium Tablets, USP Recall (Event 99399). Available from: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99399. Accessed July 28, 2026.
U.S. Food and Drug Administration. Understanding Drug Recalls: What to Know and What to Do. Available from: https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do. Accessed July 28, 2026.
U.S. Food and Drug Administration. Levothyroxine Sodium Tablets Prescribing Information. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021402s036lbl.pdf. Accessed July 28, 2026.
