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Recalls & Safety AlertsVersion 6

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

An FDA enforcement report lists an ongoing nationwide recall of one lot of Major Pharmaceuticals levothyroxine sodium tablets, initiated July 13, 2026.

By AI ReporterUpdated Aug 7, 2026, 10:40 a.m. ET
An FDA enforcement report, recall number , records an nationwide recall in the USA of Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), sold as 10 tablets (10 x 1) in unit-dose blisters per carton, Rx only. The record gives the reason as "." The recall was initiated on July 13, 2026, and the report is dated July 29, 2026. The status in the record is listed as . The product is described in the record as packaged and distributed by of Indianapolis, Indiana, and distributed by Cardinal Health of Dublin, Ohio. Identifying codes listed are bag lot numbers N02212A and N02212B, blister lot number N02212, and an expiration date of 07/2026. The NDC codes given are 55154-3558-0 for the carton and 0904-6949-61 for the blister. The quantity in the record is listed as "N/A." The FDA classified the action as , the agency's 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 FDA's published recall definitions. The agency's enforcement database records no other enforcement action by this firm; that history says nothing about fault in this action. By way of background, and separate from this recall: levothyroxine sodium is the sodium salt of levothyroxine, also called L-thyroxine or synthetic T4 (3,5,3',5'-tetraiodo-L-thyronine, CAS 51-48-9), a laboratory-manufactured version of thyroxine, a substance the thyroid gland produces in the body, according to DrugBank, a US patent on methods for preparing levothyroxine solutions, and the DailyMed label listing. Tablets of this type also contain ordinary inactive tableting ingredients such as corn starch, croscarmellose sodium, magnesium stearate, mannitol and sodium bicarbonate. The line is made in a graded series of strengths — 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200 and 300 micrograms — of which 25 mcg is the smallest; "USP" on the label signals it is made to the United States Pharmacopeia's published standard for the article. It is a finished, patient-ready medicine rather than a bulk raw material, but not something a shopper can pick off a shelf. The "Rx only" carton marking is the federal legend meaning the drug may be dispensed only on the order of a licensed prescriber, so it reaches a person through a pharmacy, according to CMS guidance on the labeling requirement under section 503(b)(4) of the FD&C Act. The 10 x 1 unit-dose format, with each tablet sealed individually in a blister, is a packaging style used for dispensing rather than over-the-counter sale, and it moves to pharmacies and care settings through a pharmaceutical wholesaler.

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Revision history

  1. Version 67 Aug 2026, 14:40current

    No new facts in the record; tightened wording and removed the "developing" note, with the recall status still listed as ongoing.

  2. Version 57 Aug 2026, 10:36

    Replaced uncited chemical formula and molecular weight with sourced product background, added excipients, strength range and Rx-only labeling citation.

  3. Version 47 Aug 2026, 06:21

    Rewrote the product-background section to match sourced reference data (synthetic origin, molecular weight, USP standard, unit-dose distribution), removed the unsupported animal-thyroid derivation claim, and added the supporting source URLs.

  4. Version 37 Aug 2026, 01:08

    Replaced the DailyMed-based product background with the clinical trial protocol and USPTO patent sources now supplied, and added the nationwide USA distribution detail from the enforcement record.

  5. Version 26 Aug 2026, 20:38

    Replaced the product background with DailyMed labelling detail (chemical identity, formula, strengths, inactive ingredients, administration) and added the packaging/dispensing context, with sources cited.

  6. Version 16 Aug 2026, 16:07

    First published.

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