Major Pharmaceuticals has initiated a voluntary nationwide recall for select lot numbers and dosage strengths of levothyroxine sodium tablets.
The recall, initiated on July 13, 2026, and classified by the U.S. Food and Drug Administration (FDA) as a Class II recall, stems from testing concerns that affected batches are subpotent—meaning the tablets may contain less active hormone ingredient than specified, reducing their therapeutic effectiveness.
What Products Are Affected by the Recall?
The recall includes 12 product lines across seven dosage strengths, packaged in unit-dose blister cartons distributed nationwide out of Indianapolis (with additional distribution by Cardinal Health):
- 25 mcg (0.025 mg): Lot #N02212 (Exp. July 2026) | NDC: 0904-6949-61
- 50 mcg (0.050 mg): Lot #N02200 (Exp. October 2026) | NDC: 0904-6950-61
- 75 mcg (0.075 mg): Lots #N02172, #N02288, #N02296 (Exp. July/Dec 2026) | NDC: 0904-6951-61
- 88 mcg (0.088 mg): Lot #N02310 (Exp. January 2027) | NDC: 0904-6952-61
- 112 mcg (0.112 mg): Lot #N02203 (Exp. September 2026) | NDC: 0904-6954-61
- 125 mcg (0.125 mg): Lot #N02266 (Exp. November 2026) | NDC: 0904-6955-61
- 150 mcg (0.150 mg): Lot #N02167 (Exp. July 2026) | NDC: 0904-6956-61
Why Subpotency Matters for Patients
Levothyroxine sodium is a synthetic hormone prescribed to manage hypothyroidism, Hashimoto’s thyroiditis, and TSH suppression following thyroid cancer treatment. Because thyroid replacement therapies require precise daily dosing, subpotent medication can result in inadequate hormone replacement.
Under-treatment or subpotent dosing may lead to a recurrence or worsening of hypothyroid symptoms, including:
- Persistent fatigue or weakness
- Unexplained weight gain
- Increased sensitivity to cold
- Muscle pain and joint stiffness
- Brain fog or difficulty concentrating
- Dry skin and thinning hair
An FDA Class II designation indicates that while exposure to the subpotent drug may cause temporary or medically reversible health consequences, the probability of severe adverse health outcomes remains low.
Important Guidance for Patients and Pharmacists
Do Not Stop Taking Your Medication: Healthcare experts strongly advise patients not to abruptly discontinue their levothyroxine without consulting a physician, as untreated hypothyroidism poses additional health risks.
Verify Your Prescription: Check the National Drug Code (NDC) and lot numbers on your blister packaging or consult your dispensing pharmacy to verify if your current supply is part of the recalled Major Pharmaceuticals lots.
Contact Your Healthcare Team: If your lot matches the recall list, contact your prescribing doctor or pharmacist to receive a replacement batch from an unaffected manufacturer.
Pharmacy Actions: Pharmacies, hospitals, and distributors holding affected inventory are advised to quarantine remaining units immediately and follow manufacturer return instructions.