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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 12 products — see all of them.
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 7000 Cardinal Pl, N/A, Dublin, OH, United States
- Classification
- Class II
- Recall number
- D-0700-2026
In the FDA's words
- Description
- 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 Subpotent Drug Lot#: N02212, Exp. Date 07/2026 Distribution: Nationwide in the USA. Affected quantity: N/A
- Hazard
- Subpotent Drug
12 products in this recall
The agency lists each product separately. Check every one you might have.
- 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 PHARMA… (this page)D-0700-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMA…D-0701-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMA…D-0702-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMA…D-0703-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHAR…D-0704-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHAR…D-0705-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHAR…D-0706-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACE…D-0707-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACE…D-0708-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACE…D-0709-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMA…D-0710-2026 · N/A
- Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMA…D-0711-2026 · N/A