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Recalls & Safety AlertsVersion 6

FDA Lists Class II Recall of Levothyroxine Sodium Tablets, 150 mcg, for Subpotency

An FDA enforcement report, recall number D-0711-2026, lists Major Pharmaceuticals recalling one lot of unit-dose levothyroxine tablets distributed nationwide, with the action listed as ongoing.

By AI ReporterUpdated Aug 7, 2026, 11:25 a.m. ET
An FDA enforcement report, recall number , lists a recall of Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), packaged as 10 tablets (10 x 1) in unit dose blisters per carton, Rx only. The record names the recalling firm as and gives the reason as "." The record lists the recall as initiated on July 13, 2026 and reported on July 29, 2026, with distribution nationwide in the USA and quantity listed as N/A. The status is listed as , so details may change. The enforcement record describes the product as packaged and distributed by , Indianapolis, IN 46268 USA, and distributed by Cardinal Health, Dublin, OH 43017, with NDC Bag: 55154-3563-0 and NDC Blister: 0904-6956-61. The identifying codes listed are bag lot # N02167A, expiration date 07/2026, and blister lot # N02167. The FDA classified the action . 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. As background on what the product is, drawn from published product labelling on DailyMed and reproduced in clinical trial protocols filed with ClinicalTrials.gov, and from patent literature: levothyroxine sodium tablets are a manufactured, prescription-only oral medicine, not a food or a natural product. The tablets contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt — levothyroxine (T4) sodium, empirical formula C15H10I4NNaO4·xH2O — produced by chemical synthesis rather than extracted from a plant or animal, and described as chemically identical to the substance made in the human thyroid gland. The active substance is compressed with inactive ingredients into small round scored tablets, this one containing 150 micrograms (0.150 mg) per tablet. The "Rx only" statement on the carton is the label statement required by federal law on drugs that may be dispensed only on a prescription. The 10 x 1 unit-dose blister carton described here is the individually sealed, one-tablet-per-pocket format supplied through wholesalers to hospital and institutional pharmacies for dispensing tablet by tablet, rather than a bottle bought off a shelf. Those holding the product would therefore be pharmacies, hospitals and care facilities, and the patients given the single-dose blisters. This background describes the product generally and says nothing about this recall. The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 15:25current

    Added headline and dek; body unchanged in substance from v5.

  2. Version 57 Aug 2026, 11:14

    Added DailyMed labelling and the "Rx only" federal labelling requirement to the product background, corrected the per-tablet strength wording to match the label sources, and named the pharmacies, hospitals and care facilities that hold unit-dose stock.

  3. Version 47 Aug 2026, 05:49

    Replaced the DailyMed-sourced product background (molecular weight, inactive ingredients) with the sourced product description from ClinicalTrials.gov protocols and patent literature, and added those source URLs.

  4. Version 37 Aug 2026, 01:37

    Added source URLs for the enforcement record, classification definition and product background; removed the uncited NCATS reference; wrote dates out in full and noted the background says nothing about this recall.

  5. Version 26 Aug 2026, 21:56

    Corrected and re-sourced the product background to DailyMed, NCATS and FDA unit-dose guidance, removing uncited molecular weight, dose and distribution-chain details; added headline, dek and source links.

  6. Version 16 Aug 2026, 16:42

    First published.

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