FirstAlerts
Recalls & Safety AlertsVersion 6

FDA Lists Class II Recall of Subpotent Levothyroxine 112 mcg Tablets Distributed by Major Pharmaceuticals

The agency's enforcement report for recall number D-0704-2026 records an ongoing, nationwide recall of a single lot, initiated July 13, 2026.

By AI ReporterUpdated Aug 7, 2026, 9:26 a.m. ET
The FDA enforcement report for recall number lists an , nationwide recall of Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), packaged and distributed by of Indianapolis, Indiana, under NDC 0904-6954-61. The record gives the reason as "" and identifies the affected product as Lot #N02203, with an expiration date of 09/2026. The recall was initiated on July 13, 2026, and the report is dated July 29, 2026. The quantity of product involved is listed as N/A. Distribution is listed as nationwide in the USA, and the status as . 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. The product is a finished prescription medicine in tablet form. According to the FDA-published labelling on the National Library of Medicine's DailyMed, the active substance is synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt — the T4 compound that the labelling describes as chemically identical to the substance produced in the human thyroid gland. The tablets are scored and colour-coded and contain inactive ingredients such as corn starch, croscarmellose sodium, magnesium stearate, mannitol and sodium bicarbonate, with formulations varying by manufacturer, plus strength-specific colour additives. DailyMed labelling lists the drug in strengths of 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200 and 300 mcg, so the recalled 112 mcg item is one strength within a colour-coded family. "Rx only" on the carton means US law allows it to be supplied only against a prescription; a consumer cannot buy it off a shelf. The packaging bears on who would have it. The recalled presentation is 100 tablets as ten 10-tablet unit-dose blister cards in a carton. Under the USP's packaging-practice chapter on repackaging solid oral drug products into unit-dose containers, that format is produced by repackagers and distributed onward to hospitals, long-term care facilities and pharmacies rather than sold over a counter, with each single dose kept sealed, labelled and barcoded until it is given to a patient. It is not a bulk ingredient. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 13:26current

    No change to the recall record; republished with the full source list attached and attribution to the FDA enforcement report and DailyMed/USP reference labelling made explicit.

  2. Version 57 Aug 2026, 11:57

    Corrected the tablet strength wording to the record's "112 mcg (0.0112 mg)", replaced the inactive-ingredient and packaging descriptions with those supported by the DailyMed and USP reference sources, and added the labelled strength range.

  3. Version 47 Aug 2026, 06:58

    Corrected the inactive-ingredient list and unit-dose description to match the cited DailyMed and FDA references, and removed the empirical formula and 25–300 mcg strength range, which are not in the source set.

  4. Version 37 Aug 2026, 02:16

    Corrected the product description to the DailyMed labelling (formula, excipients, strength range, USP and Rx-only meaning), removed the unsourced molecular weight and inactive-ingredient list, added the nationwide distribution detail, and added the DailyMed, CMS and USP reference URLs.

  5. Version 26 Aug 2026, 21:20

    Removed unsupported claims that the product comes in strengths from 25 to 300 micrograms and that the listing is a repackaged label; added the labeling's chemical description of levothyroxine sodium and clarified the unit-dose distribution context.

  6. Version 16 Aug 2026, 17:23

    First published.

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