The FDA has issued a nationwide Class II recall for specific lots of levothyroxine sodium tablets distributed by Major Pharmaceuticals after testing found some tablets to be subpotent. Affected products include certain 100-tablet cartons and 10-tablet blister packs; lot numbers and expiration dates are listed above. If you or a family member takes levothyroxine, check your supply, contact your pharmacist or prescriber if your lot is listed, and do not stop medication without medical guidance.
Nationwide Recall: Certain Levothyroxine Tablets From Major Pharmaceuticals Are Subpotent, FDA Warns
FDA Recalls Popular Thyroid Medication NationwideOrganic Media - Getty Images
The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of specific lots of levothyroxine sodium tablets distributed by Major Pharmaceuticals. Levothyroxine is a commonly prescribed thyroid medication used to treat hypothyroidism and goiter.
Why: FDA testing found some tablets to be subpotent, meaning they may contain less active ingredient than intended. The agency classified this as a Class II recall, indicating the defect could cause temporary or reversible health effects.
Which Products Are Affected
Affected products were packaged as 100-tablet cartons and 10-tablet blister packs (sold individually or bundled in cartons of 10 blister packs). Check the lot numbers and expiration dates listed below to see if your supply is affected.
100-Tablet Cartons
- 25 mcg — Lot Number: N02212; Expiration Date: 07/2026
- 50 mcg — Lot Number: N02200; Expiration Date: 10/2026
- 75 mcg — Lot Numbers: N02172, N02296, N02288; Expiration Dates: 07/2026, 12/2026
- 88 mcg — Lot Number: N02310; Expiration Date: 01/2027
- 112 mcg — Lot Number: N02203; Expiration Date: 09/2026
- 125 mcg — Lot Number: N02266; Expiration Date: 11/2026
- 150 mcg — Lot Number: N02167; Expiration Date: 07/2026
10-Tablet Blister Packs
- 25 mcg — Bag Lot Numbers: N02212A, N02212B; Blister Lot Number: N02212; Expiration Date: 07/2026
- 50 mcg — Bag Lot Numbers: N02200A, N02200B; Blister Lot Number: N02200; Expiration Date: 10/2026
- 75 mcg — Bag Lot Numbers: N02172A, N02172B, N02288A, N02288B; Blister Lot Numbers: N02172, N02288; Expiration Dates: 07/2026, 12/2026
- 125 mcg — Bag Lot Numbers: N02266A, N02266B; Blister Lot Number: N02266; Expiration Date: 11/2026
- 150 mcg — Bag Lot Number: N02167A; Blister Lot Number: N02167; Expiration Date: 07/2026
What To Do If Your Medication Is Affected
1. Check your supply: Compare the lot number and expiration date on your carton or blister pack with the lists above.
2. Contact your pharmacist or prescriber: If your lot is affected, reach out to your pharmacy or healthcare provider for guidance on obtaining a replacement or arranging a return. Do not stop taking levothyroxine without medical advice.
3. Watch for symptoms of under-treatment: Because the recalled tablets may be subpotent, people taking them could notice signs of low thyroid hormone, such as fatigue, unexplained weight gain, increased sensitivity to cold, constipation, dry skin, or hair thinning. If you notice new or worsening symptoms, contact your clinician.
4. Lab monitoring: Your provider may recommend checking thyroid-stimulating hormone (TSH) and free T4 levels to ensure your dose remains appropriate after switching products.
5. Return or disposal: Follow your pharmacist’s or the FDA’s instructions for returning or safely disposing of recalled medication.
For full details and the official recall notice, consult the FDA website or contact your pharmacy or healthcare provider.
Help us improve.
