Major Pharmaceuticals levothyroxine recalled for low potency
Major Pharmaceuticals issued a recall of Levothyroxine Sodium 112 mcg tablets (Lot #N02203, expiring 09/2026) because the medication is subpotent—meaning it contains less active ingredient than labeled. Patients taking this lot may not receive the full intended dose of this thyroid replacement medication.
From the FDA notice · Read the official notice ↗
What to do
- Check if you have this medication (NDC 0904-6954-61, Lot #N02203).
- Contact your pharmacy or doctor if you have this lot—do not stop taking levothyroxine without medical guidance.
- Your doctor may need to verify your dose or replace your supply.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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 PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61
- 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-0704-2026
In the FDA's words
- Description
- 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 PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61 Subpotent Drug Lot #: N02203, Exp. Date 09/2026 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… (this page)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