FirstAlerts
Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of Levothyroxine Sodium Tablets Over Subpotency

An FDA enforcement report lists a nationwide recall of 125 mcg levothyroxine sodium unit-dose tablets packaged by Major Pharmaceuticals, initiated July 13, 2026.

By AI ReporterUpdated Aug 7, 2026, 9:55 a.m. ET
An FDA enforcement report, recall number , records a nationwide recall in the United States of Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg) — the strength is written that way in the record — packaged in cartons of 10 tablets (10 x 1) in unit-dose blisters. The record names the recalling firm as and gives the reason as "." The recall was initiated on July 13, 2026, and the report is dated July 29, 2026. The status is listed as , and the quantity of product involved is given as N/A. This is a developing record and may be updated by the agency. The product is described in the record as packaged and distributed by , Indianapolis, IN 46268 USA, and distributed by Cardinal Health, Dublin, OH 43017. The identifying codes listed are bag lot numbers N02266A and N02266B, blister lot number N02266, and expiration date 11/2026, with NDC Bag 55154-3562-0 and NDC Blister 0904-6951-61. The FDA classified the action as . The agency defines as its middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The FDA's enforcement database records no other enforcement action by this firm; that history says nothing about fault in this action. As background on what the product is: according to DailyMed labelling for levothyroxine sodium tablets and FDA approved labeling, the active ingredient is synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt, an iodine-containing sodium salt with the empirical formula C15H10I4NNaO4·xH2O — a manufactured compound chemically identical to a substance produced in the human thyroid gland, made in pharmaceutical plants rather than extracted from a natural source. It is pressed into small oral tablets containing 125 micrograms (0.125 mg) of the active substance, with inactive ingredients that on comparable labels include colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, corn starch, acacia and sodium starch glycolate; "USP" indicates manufacture to the United States Pharmacopeia monograph standard for that ingredient and dosage form. It is a finished prescription medicine rather than a bulk ingredient, and the "Rx only" statement means U.S. law allows it to be dispensed only against a prescription. The FDA describes the 10 x 1 unit-dose blister format as intended for institutional "unit dose" dispensing, for example in hospitals, where one dose is delivered at the time of administration; such packs move through a wholesale distributor to pharmacies, hospitals and similar facilities rather than directly to shoppers. This background says nothing about this recall.

Was this report accurate and useful?

Sources

Revision history

  1. Version 67 Aug 2026, 13:55current

    Added headline and dek, moved the firm's clean enforcement history up beside the Class II definition, and split the product background into two paragraphs; no facts changed.

  2. Version 57 Aug 2026, 10:58

    Product background revised to match supplied reference sources: added empirical formula, USP monograph explanation and full inactive-ingredient list; removed the PubChem citation and the unsupported claim about twelve dose strengths and color additives.

  3. Version 47 Aug 2026, 06:01

    Replaced the product background with DailyMed/PubChem-sourced detail (synthetic T4 salt, inactive ingredients, twelve strengths, FDA unit-dose definition), dropped the unsourced veterinary-formulation and colour/imprint lines and the converted 0.125 mg figure, and added the supporting reference URLs.

  4. Version 37 Aug 2026, 01:25

    Product background re-sourced to the National Library of Medicine's PubChem thyroxine entry, replacing the DailyMed-based description, and a note added that veterinary levothyroxine formulations are separate products.

  5. Version 26 Aug 2026, 21:06

    Corrected the product background to the DailyMed label description (excipients, 25–300 mcg strength range, dispensing settings) and added the reference source links.

  6. Version 16 Aug 2026, 16:31

    First published.

How we work

This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.

Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.

Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.

None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.