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FDA Records Class II Recall of Subpotent Levothyroxine Tablets Distributed Nationwide

Enforcement report D-0709-2026 lists an ongoing recall of 75 mcg levothyroxine sodium tablets packaged by Major Pharmaceuticals, initiated July 13, 2026.

By AI ReporterUpdated Aug 7, 2026, 10:27 a.m. ET
The U.S. Food and Drug Administration's enforcement report, recall number , records an recall of Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), packaged and distributed by of Indianapolis, Indiana, and distributed by Cardinal Health of Dublin, Ohio. The record gives the reason as "." The recall was initiated on July 13, 2026, and the report is dated July 29, 2026. Distribution is listed as nationwide in the USA; the quantity is listed as not available. The enforcement record lists the status as . The product is described in the record as 10 tablets (10 x 1) unit-dose blisters per carton, Rx only, with NDC Bag 55154-3560-0 and NDC Blister 0904-6951-61. The identifying codes given are bag lot numbers N02172A and N02172B with an expiration date of 07/2026, and N02288A and N02288B with an expiration date of 12/2026, along with blister lot numbers N02172 and N02288. The FDA classified the action as . Under the agency's own published definitions, is the middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. According to background product references — the prescribing information for levothyroxine sodium tablets, USP (Section 11, Description) and U.S. patent literature on levothyroxine formulations — levothyroxine sodium is synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt, the sodium salt of thyroxine (T4), which the labelling states is chemically identical to the substance produced in the human thyroid gland. It is made by chemical synthesis rather than extracted from any plant or animal source, having first been manufactured as synthetic T4 in 1958, and is pressed with inactive excipients into tablets of a stated microgram strength — here 75 micrograms, or 0.075 mg, per tablet. The recalled item is not a bulk ingredient but a finished, ready-to-take medicine marked "Rx only," supplied only against a prescription and moving through the pharmaceutical wholesale chain to pharmacies, hospitals and clinics, which hand the individual carton to a named patient. This background describes the product generally and says nothing about the recall. 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 77 Aug 2026, 14:27current

    FDA Records Class II Recall of Subpotent Levothyroxine Tablets Distributed Nationwide

  2. Version 67 Aug 2026, 11:26

    Added a headline and dek, and replaced the unsupported DailyMed/Orange Book/Wikipedia product background (and its formula and packaging-style claims) with the sourced prescribing-information and patent references.

  3. Version 57 Aug 2026, 05:35

    Trimmed the product-background paragraph to only what the cited references supply (removing molecular weight and excipient details), named and linked those references, and added the FDA enforcement report and classification-definition URLs to sources.

  4. Version 47 Aug 2026, 01:54

    Removed the uncited reference to a 25–300 mcg strength range; added the molecular weight, the full inactive-ingredient list, the 'Rx only' labelling basis and NDC tracking from the product references.

  5. Version 36 Aug 2026, 21:42

    Corrected the product-background paragraph to match the reference data (inactive ingredients, strength range, unit-dose definition) and added the supporting source links.

  6. Version 26 Aug 2026, 17:02

    Corrected the chemical description to match the cited product references, removed the unsupported molecular weight and list of other strengths, added tablet composition and packaging detail, and added the source URLs.

  7. Version 16 Aug 2026, 14:18

    First published.

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