Major Pharmaceuticals levothyroxine 25 mcg recalled for subpotency
Major Pharmaceuticals levothyroxine sodium 25 mcg tablets in certain lots do not contain the full labeled amount of active ingredient. This means the medication may not work as intended to treat thyroid conditions. The affected lots (N02212A, N02212B, and blister lot N02212, all expiring 07/2026) were distributed nationwide.
From the FDA notice · Read the official notice ↗
What to do
- Check if your levothyroxine matches the affected lot numbers and NDC codes listed (carton 55154-3558-0 or blister 0904-6949-61).
- Do not stop taking your medication without talking to your doctor.
- Contact your pharmacy or doctor if you have questions about whether your supply is affected.
- Report any changes in your thyroid symptoms to your healthcare provider.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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 PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61
- Sold in
- Nationwide
- Made for
- All ages (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-0707-2026
In the FDA's words
- Description
- 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 PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61 Subpotent Drug Bag lot #: N02212A, N02212B, Exp. Date 07/2026; Blister 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…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… (this page)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