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Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of Major Pharmaceuticals Levothyroxine Tablets Over Subpotency

The agency's enforcement report for recall D-0705-2026 lists one lot of 125 mcg levothyroxine sodium tablets, distributed nationwide, with the action ongoing.

By AI ReporterUpdated Aug 7, 2026, 9:55 a.m. ET
The U.S. Food and Drug Administration's enforcement report for recall number records a nationwide recall in the USA of Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 tablets per carton in 10 x 10 unit-dose blisters, marked Rx only and packaged and distributed by , Indianapolis, IN 46268 USA. The record lists NDC 0904-6955-61 and lot number N02266 with an expiration date of 11/2026. The stated reason is "." The quantity is listed as N/A. The recall was initiated on 13 July 2026 and reported on 29 July 2026, and the FDA record lists its status as — this remains a developing action. The FDA classified the recall as . Under the agency's own definitions, is its middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. According to the agency's enforcement database, no other enforcement action by this firm is recorded. That is context only and says nothing about fault in this action. For background on the product itself, and not on this recall: levothyroxine sodium is a synthetic, laboratory-made chemical — crystalline L-3,3',5,5'-tetraiodothyronine sodium salt, formula C15H10I4NNaO4·H2O, molecular weight about 798.86 g/mol anhydrous — which, per the drug labeling published on DailyMed, the U.S. National Library of Medicine's labeling database, is identical to the T4 substance produced in the human thyroid gland. In this product it is pressed into tablets containing 125 micrograms (0.0125 mg) of the active ingredient along with inactive tableting ingredients; labels for levothyroxine sodium tablets list excipients such as microcrystalline cellulose, lactose, corn starch, acacia, colloidal silicon dioxide, magnesium stearate and sodium starch glycolate. "USP" means the tablets are made to the United States Pharmacopeia compendial standard, and they are swallowed by mouth one tablet at a time. This is a finished, ready-to-take prescription drug product rather than a bulk ingredient sold to manufacturers. The "Rx only" marking means, under FDA labeling rules, that it may be dispensed only on a prescription and cannot be bought off the shelf; an individual receives it from a pharmacy. The 100-tablet, 10 x 10 unit-dose blister presentation is the format the FDA describes as packaging for delivery of a single dose at the time of administration, typically for institutional settings such as hospitals, rather than the loose bottle a person usually carries home. It is identified in trade by an NDC number.

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Revision history

  1. Version 67 Aug 2026, 13:55current

    No new facts; added headline and dek and retained the v5 text unchanged.

  2. Version 57 Aug 2026, 11:48

    Product background updated to the DailyMed/FDA reference data: corrected chemical description and excipient list, and added that the 10 x 10 unit-dose blister carton is the format FDA describes as typical for institutional settings such as hospitals.

  3. Version 47 Aug 2026, 07:07

    Corrected product background to match the cited references — removed the unsupported "chemically identical to T4" wording and the 25–300 mcg strength range, added the compound formula and CAS number and named PubChem and DailyMed as the sources.

  4. Version 37 Aug 2026, 02:11

    Replaced the PubChem-sourced chemical description (molecular formula, animal-gland isolation) with the DailyMed labeling description, added the blister/strength-range packaging detail, and cited the DailyMed label URLs.

  5. Version 26 Aug 2026, 21:27

    Replaced unsourced Wikipedia-based chemistry description with PubChem and DailyMed reference data, and corrected the packaging/distribution background to the sourced description.

  6. Version 16 Aug 2026, 17:12

    First published.

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