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FDA Records Class II Recall of 88 mcg Levothyroxine Tablets Distributed by Major Pharmaceuticals

An FDA enforcement report lists one lot of Levothyroxine Sodium Tablets, USP, 88 mcg recalled nationwide as subpotent, with the action ongoing.

By AI ReporterUpdated Aug 7, 2026, 10:01 a.m. ET
An FDA enforcement report, recall number , records an recall of Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), packaged and distributed by of Indianapolis, Indiana. The record gives the reason as "." The recall was initiated on July 13, 2026, and the report is dated July 29, 2026. The action is listed as . According to the FDA record, the affected product is sold as 100 tablets — ten unit-dose blister cards of ten — per carton, Rx only, under NDC 0904-6952-61, and is identified by Lot #N02310 with an expiration date of 01/2027. Distribution is listed as The quantity in the recall is listed in the record as "N/A." The FDA classified the recall as . By the agency's own definition, is its middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote. For readers checking whether they hold the product: levothyroxine sodium is a synthetic crystalline chemical — the sodium salt of L-3,3',5,5'-tetraiodothyronine, also written L-thyroxine or T4 — with the formula C15H10I4NNaO4·H2O and a molecular weight of about 798.86 g/mol (anhydrous). FDA-approved labeling published on DailyMed states the synthetic material is chemically identical to the T4 substance produced in the human thyroid gland. It is pressed into small colour-coded oral tablets combining a microgram-scale quantity of active substance with inactive tabletting ingredients such as microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, povidone, mannitol, crospovidone, sodium lauryl sulfate, sucrose and butylated hydroxyanisole, plus colour additives that differ by strength; the 88 mcg strength is one of a standard ladder running from 25 mcg to 300 mcg. It is a finished prescription medicine, not a bulk ingredient, and the "Rx only" carton can be supplied in the United States only on a licensed prescriber's order. The 10-cards-of-10 unit-dose format is the style used for dispensing one sealed tablet at a time, typically supplied to hospitals, nursing homes and other institutional pharmacies rather than as a household bottle — so the holders are pharmacies and care institutions, and downstream of them patients who received tablets from such packs. This description is background about the product generally and says nothing about this recall. 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, 14:01current

    No new facts in the record; added headline and standfirst and listed the underlying FDA enforcement report and labeling sources as citations.

  2. Version 57 Aug 2026, 11:07

    Replaced the PubChem/DrugBank product background with FDA labeling published on DailyMed, adding molecular weight, inactive ingredients, the strength range and the point that the unit-dose format is typically supplied to institutional pharmacies.

  3. Version 47 Aug 2026, 05:56

    Replaced the product-description section with the sourced PubChem/DrugBank chemical and packaging background, removing the previously included inactive-ingredient list, thyroid-equivalence wording and institutional-dispensing detail that are not in the fact set.

  4. Version 37 Aug 2026, 01:32

    Replaced the raw-chemical product description with one sourced to the DailyMed and FDA labeling and the FDA unit-dose guidance, and added those source URLs.

  5. Version 26 Aug 2026, 21:12

    Replaced the DailyMed-based product description with the chemical-reference description of levothyroxine sodium and its packaging, added source links, and dropped the 'developing' line.

  6. Version 16 Aug 2026, 16:39

    First published.

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