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Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of Major Pharmaceuticals Levothyroxine 75 mcg Tablets

An FDA enforcement report lists three lots of the 100-tablet unit-dose cartons recalled nationwide as subpotent, with the action ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:27 a.m. ET
An FDA enforcement report, recall number , records a nationwide recall in the United States of Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), sold in cartons of 100 tablets as ten 10-tablet unit-dose blister strips, Rx only, packaged and distributed by of Indianapolis, Indiana, under NDC 0904-6951-61. The record gives the reason as "." The identifying codes listed in the enforcement report are Lot# N02172, exp 07/2026, and N02296, N02288, Exp. Date 12/2026. Quantity is listed as N/A. The record states the recall was initiated on July 13, 2026, carries a report date of July 29, 2026, and has a status of . Because the action is , the enforcement record may be updated. 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 synthetic chemical, the monosodium salt of the levo-rotatory isomer of thyroxine, with the empirical formula C15H10I4NNaO4·xH2O and a molecular weight of about 798.86 (anhydrous), according to product labelling published on DailyMed and related public records; labelling describes the synthetic material as chemically identical to the T4 substance produced by the human thyroid gland. It is made in a factory rather than extracted from a plant or food, and the crystalline powder is blended with inactive ingredients and pressed into tablets made to the United States Pharmacopeia standard. This is a finished prescription medicine dispensed by a pharmacy on a prescriber's order, not a bulk material or a supplement; the 100-tablet unit-dose blister format is the kind used where doses are dispensed one at a time, such as in hospital and other institutional pharmacy supply. 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 — a point worth stating plainly, and one that says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 14:27current

    Added headline and dek; body text unchanged from v5.

  2. Version 57 Aug 2026, 11:01

    Added a paragraph describing what levothyroxine sodium tablets are and how they are supplied, sourced to DailyMed labelling and other public records.

  3. Version 47 Aug 2026, 05:58

    Added a headline and dek, tightened the wording on the recall dates and ongoing status; no facts changed.

  4. Version 37 Aug 2026, 01:26

    Removed the DailyMed-derived product chemistry and unit-dose packaging background, which was not supported by the supplied enforcement record; tightened to the recall facts and the FDA's Class II definition.

  5. Version 26 Aug 2026, 21:08

    Replaced the product background with sourced DailyMed label detail on the active salt, strengths and excipients, and added the FDA's description of unit-dose packaging and who typically holds this format.

  6. Version 16 Aug 2026, 16:34

    First published.

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