FDA-Drug2026-07-29Class IICHEMICAL

Major Pharmaceuticals levothyroxine sodium tablets recalled for subpotency

LABEL MIX UPNationwide distribution

Major Pharmaceuticals levothyroxine tablets recalled for subpotency

Major Pharmaceuticals is recalling one lot of Levothyroxine Sodium Tablets, USP, 25 mcg due to subpotency — meaning the tablets contain less active ingredient than labeled. This affects Lot N02212 with an expiration date of 07/2026. Patients taking subpotent levothyroxine may not receive the full intended dose of this thyroid hormone replacement medication.

  • Check if you have Levothyroxine Sodium Tablets, USP, 25 mcg (NDC 0904-6949-61) with Lot N02212.
  • Contact your pharmacist or doctor if you have this lot — do not stop taking the medication without guidance.
  • Your doctor may need to adjust your dose or switch you to a replacement supply.
  • Report any adverse effects to your doctor or the FDA MedWatch program.
Hazard

Subpotent Drug

Sold states
Nationwide in the USA.
Affected count
N/A
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0700-2026

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