Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Jul 13, 2026 (3 months ago)

Levothyroxine Sodium Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Subpotent Drug

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

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

Affected NDC 0904-6949-61

Compare with the code on your package — it is the most precise check available.

Drug: Levothyroxine Category: Thyroid Medication

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Levothyroxine Sodium
NDC 00904-6949
.025 mg/1 Tablet
Oral
Major Pharmaceuticals Rx
Recalling firm
Major Pharmaceuticals
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0700-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other Levothyroxine recalls

See all

Other recalls by Major Pharmaceuticals

All 2026 recalls