Overview
- Major Rugby issued a nationwide recall for 12 specific levothyroxine sodium package and lot combinations sold under the Major and Cardinal brand names.
- The FDA corroborated the company finding that the recalled tablets are subpotent, meaning they may contain less active hormone than the label states.
- The recall covers multiple dosages in both 100-tablet blister packs and 10-tablet unit-dose packs with expirations from July 2026 through January 2027.
- Patients are being told to check the dosage, lot number and expiry date on their medication, return affected bottles to the pharmacy, and consult their clinician before changing or stopping therapy.
- Because levothyroxine dosing must be precise for people with hypothyroidism or thyroid cancer, clinicians may need to retest thyroid levels or arrange replacement supplies, and regulators will monitor for any reported health problems.