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FDA Records Ongoing Class II Recall of Major Pharmaceuticals Levothyroxine 50 mcg Tablets

An FDA enforcement report published July 29, 2026 lists one lot of 50 mcg levothyroxine sodium tablets recalled nationwide as a subpotent drug.

By AI ReporterUpdated Aug 7, 2026, 10:48 a.m. ET
An FDA enforcement report published July 29, 2026 records an recall of Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), packaged and distributed by of Indianapolis, Indiana. The record lists the action under recall number and gives an initiation date of July 13, 2026. The reason stated in the record is "." Distribution is listed as nationwide in the USA, and the affected product is identified as Lot #N02200, Exp. Date 10/2026, NDC 0904-6950-61. The quantity is listed in the record as "N/A." The status is listed as , and details may change as the agency updates the record. The FDA classified the action as . By the agency's own published definition, is the 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 rather than a bulk ingredient sold to manufacturers. According to DailyMed, the drug labelling service of the US National Library of Medicine, levothyroxine sodium is a synthetic, laboratory-made compound — the crystalline sodium salt of L-thyroxine, also written T4 or L-3,3',5,5'-tetraiodothyronine — an iodine-containing substance whose structure is identical to one the human thyroid gland produces. It is pressed into tablets holding a precisely measured microgram-level amount of the active compound, in this presentation 50 mcg (0.050 mg), together with inactive tabletting ingredients such as microcrystalline cellulose, mannitol, magnesium stearate, sodium starch glycolate and colour additives. "USP" after the name signifies that the tablets are made to the United States Pharmacopeia compendial standard. The recalled presentation, as described in the enforcement record, is a carton of 100 tablets arranged as ten strips of ten unit-dose blisters. The carton is marked "Rx only," the statement US federal law requires on a drug that may be dispensed only on a prescriber's order under section 503(b) of the Federal Food, Drug, and Cosmetic Act. The FDA describes unit-dose packaging as intended for institutional use, such as hospitals, where a single dose is delivered to the patient at the time it is given; cartons of this kind are prepared by packagers and repackagers and sent to hospitals, distributors and pharmacies rather than direct to the public. The parties holding stock are therefore pharmacies, hospitals and other institutions, while individual tablets end up with patients to whom they were dispensed. 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, 14:48current

    No new facts in the record; added the source links for the FDA enforcement report, classification definition and product background.

  2. Version 57 Aug 2026, 10:47

    Replaced ClinicalTrials.gov-sourced chemistry description (formula and molecular weight) with DailyMed-sourced product description, and expanded the packaging paragraph with the FDA's unit-dose labeling guidance on institutional distribution.

  3. Version 47 Aug 2026, 06:12

    Product description resourced to NIH-hosted prescribing/study documents with chemical formula and molecular weight, replacing the DailyMed attribution and the unsupported inactive-ingredient list; packaging paragraph tightened to the wording of the enforcement record.

  4. Version 37 Aug 2026, 01:16

    Removed chemical formula, molecular weight and statutory citation not in the fact set, corrected the inactive-ingredient list to the labelling cited, and added the source URLs for the enforcement record, classification definition and product labelling.

  5. Version 26 Aug 2026, 20:55

    Added headline and dek, the USP standard and molecular weight detail, and the statutory citation for the prescription-only requirement; tightened institutional-packaging wording.

  6. Version 16 Aug 2026, 16:20

    First published.

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