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Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of Major Pharmaceuticals Levothyroxine 25 mcg Tablets for Subpotency

The agency's enforcement report lists one lot of the thyroid medication, distributed nationwide, as recalled for being subpotent; the action is ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:47 a.m. ET
The FDA enforcement report for recall number records a recall of Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), packaged and distributed by of Indianapolis, Indiana, with the reason given as "." The record lists the recall as initiated on 13 July 2026 and reported on 29 July 2026, with distribution described as The status is listed as , and the recall remains a developing matter. According to the enforcement report, the affected product is sold as 100 tablets (10 x 10 unit dose blisters) per carton, Rx only, under NDC 0904-6949-61, and is identified by Lot# N02212 with an expiration date of 07/2026. The record lists the quantity as N/A. The agency classified the action as . The FDA defines as its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. For readers checking what they may have: according to product labeling published on DailyMed by the U.S. National Library of Medicine, levothyroxine sodium is L-3,3',5,5'-tetraiodothyronine sodium salt — also written as L-thyroxine or T4 — a manufactured crystalline compound with the formula C15H10I4NNaO4·H2O and an anhydrous molecular weight of about 798.86 g/mol, described in the approved labeling as chemically identical to the T4 produced in the human thyroid gland and made in a laboratory rather than extracted from animals. Labels for levothyroxine sodium tablets, USP list inactive tableting ingredients such as butylated hydroxyanisole, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium lauryl sulfate, sucrose and a color additive; the 25 mcg tablets are colored, capsule-shaped and scored. Each tablet here contains 25 micrograms of the active substance and is swallowed by the person taking it. This is a finished, ready-to-take medicine rather than a bulk ingredient: the carton is marked "Rx only," meaning that under 21 U.S.C. 353(b) it may be dispensed only on the prescription of a licensed practitioner, reaching patients through a pharmacy or an institution such as a hospital or nursing home. The 10-by-10 unit dose blister format, with one tablet sealed per cavity, is the packaging style used where doses are dispensed one at a time rather than from a bottle. 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, 14:47current

    Added headline and dek; consolidated the classification and product-description paragraphs, with no change to the underlying facts.

  2. Version 57 Aug 2026, 10:55

    Corrected the product description to the inactive-ingredient list and chemical details given in the DailyMed labeling, and added the prescription-only statutory citation and tablet appearance.

  3. Version 47 Aug 2026, 06:03

    Replaced the unsourced ChemicalBook product description with the DailyMed/CMS-sourced description of the tablet, its ingredients and its prescription-only dispensing, and added those source URLs.

  4. Version 37 Aug 2026, 01:23

    Replaced the product-description paragraph with the chemical properties record from ChemicalBook, removing the DailyMed-sourced ingredient and strength details.

  5. Version 26 Aug 2026, 21:05

    Product-description paragraph rewritten to match the sourced reference data (full chemical name, listed inactive ingredients, strength range, prescription-only supply) and to remove unsourced details such as the CAS number and USP monograph claim.

  6. Version 16 Aug 2026, 16:30

    First published.

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