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FDA Records Class II Recall of Subpotent 50 mcg Levothyroxine Tablets

An FDA enforcement report lists an ongoing nationwide recall of unit-dose levothyroxine sodium tablets packaged and distributed by Major Pharmaceuticals, initiated July 13, 2026.

By AI ReporterUpdated Aug 7, 2026, 10:56 a.m. ET
An FDA enforcement report, recall number , records an recall of Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), packaged as 10 tablets (10 x 1) in unit-dose blisters per carton. The record lists the reason as "." The firm is named as , and the product description states the product is packaged and distributed by of Indianapolis, Indiana, and distributed by Cardinal Health of Dublin, Ohio. The recall was initiated on July 13, 2026, and reported on July 29, 2026, according to the same record. The action is listed as , and this account is based on that enforcement record alone. The identifying codes given in the record are bag lot numbers N02200A and N02200B, blister lot number N02200, and an expiration date of 10/2026. The NDC numbers listed are 55154-3559-0 for the bag and 0904-6950-61 for the blister. Distribution is listed as The quantity is listed as N/A. The FDA classified the action as . By the agency's own definition, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. Levothyroxine sodium is a prescription medicine taken as a whole tablet. According to background reference sources including the NCATS Inxight Drugs database and the U.S. Pharmacopeia, it is the levo isomer of thyroxine (T4), also written as 3,5,3',5'-tetraiodo-L-thyronine, CAS number 51-48-9 — the same molecule the thyroid gland produces naturally, but made synthetically in a factory rather than extracted from an animal or plant. It is formulated here as a finished solid oral tablet made to the USP monograph "Levothyroxine Sodium Tablets," which requires each tablet to contain between 95.0% and 105.0% of the labelled amount of the active chemical; the drug substance is combined with inactive excipients and pressed into small scored, coloured, debossed tablets. The carton is marked "Rx only," meaning it can be supplied only against a prescriber's order and reaches a person through a pharmacy or hospital ward rather than direct purchase. The 10 x 1 unit-dose blister format is one the FDA describes as intended for delivering a single dose to a patient at the moment of administration in institutional settings such as hospitals; such packs are typically produced by repackaging firms and move through a wholesale distributor to hospitals, long-term-care facilities and pharmacies. Those holding the product are therefore institutional pharmacies, care facilities and the patients dispensed to from them — not retail shoppers or industrial buyers. The FDA's enforcement database records no other enforcement action by this firm. That is context only and says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:56current

    Condensed the product-description paragraphs into one and tightened the headline and dek; no facts added or removed.

  2. Version 57 Aug 2026, 11:39

    Replaced patent-derived product background with USP monograph detail (95.0–105.0% content requirement) and the FDA's description of unit-dose packaging, and added the supporting reference URLs.

  3. Version 47 Aug 2026, 05:24

    Product-background paragraph rewritten to match the sourced reference data (synthetic T4 sodium salt, CAS number, USP standards, patent sources) and unsupported excipient list removed; patent sources added to citations.

  4. Version 37 Aug 2026, 02:05

    Added headline and dek; expanded the product description with the DailyMed-listed synthetic T4 composition and inactive ingredients.

  5. Version 26 Aug 2026, 21:29

    Rewrote the product-description paragraph to match the DailyMed-sourced reference wording and added who typically stocks and receives the unit-dose cartons; added headline and dek.

  6. Version 16 Aug 2026, 17:11

    First published.

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