Nationwide Recall of Levothyroxine Sodium Tablets Over Subpotency

On July 13 the U.S. Food and Drug Administration (FDA) announced a nationwide recall of levothyroxine sodium tablets after testing showed the products were “subpotent,” meaning they contain less active ingredient than labeled. The agency classified the recall as Class II, indicating that use of the medication may cause temporary or medically reversible adverse health consequences, while the probability of serious harm is remote.

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Levothyroxine sodium is a synthetic thyroid hormone prescribed to treat hypothyroidism, goiter (enlarged thyroid gland), and certain thyroid cancers. The medication works by directly replacing or supplementing natural thyroid hormone, so precise dosing is critical for maintaining stable hormone levels.

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The recalled lots were packaged and distributed by a pharmaceutical company identified in different reports as Major Rugby or Major Pharmaceuticals. Distribution began in early 2025 and continued through 2026, reaching pharmacies across the United States.

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• Dosage strengths affected: 25 µg, 50 µg, 75 µg, 88 µg, 112 µg, 125 µg, and 150 µg.

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• Packaging formats: 10-count blister packs sold individually or in cartons containing ten such blisters (100 tablets total).

FDA orders Levothyroxine Recall 2026 of subpotent tablets

• Lot numbers and expiration dates: Multiple lot numbers spanning expiration dates from July 2026 to January 2027 were listed in the FDA notice.

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• Recall classification: Class II (temporary or reversible health effects).

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The FDA did not disclose the total number of tablets recalled.

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• The FDA’s recall notice described the tablets as subpotent and explained the Class II designation.

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• The Mayo Clinic reiterated that levothyroxine sodium tablets are used to treat hypothyroidism, enlarged thyroid glands, and certain thyroid cancers.

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Healthcare providers and pharmacists were instructed to quarantine any remaining inventory, notify patients, and follow standard recall procedures. Patients were advised to check lot numbers and expiration dates on their medication packaging and to consult their physician or pharmacist before discontinuing treatment.

FDA orders Levothyroxine Recall 2026 of subpotent tablets

Because levothyroxine directly replaces thyroid hormone, even modest reductions in potency can lead to under-treatment. Symptoms of insufficient dosing include fatigue, weight gain, cold intolerance, and cognitive difficulties. While the FDA assessed the risk of serious injury as remote, patients relying on precise hormone replacement may experience a return of hypothyroid symptoms until the issue is corrected.

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• Early 2025: Distribution of the affected levothyroxine tablets begins.

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• July 13: FDA issues Class II recall and public notice.

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• July 17: FDA confirms the Class II designation, emphasizing that adverse effects are likely temporary and reversible.

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• Company name: Some outlets refer to the manufacturer as Major Rugby, while others use Major Pharmaceuticals. Both names appear in the recall communications, creating ambiguity about the corporate identity.

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• Exact quantity recalled: The FDA notice did not specify how many tablets were affected, leaving the scale of the recall unclear.

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Patients and providers should continue to monitor FDA updates and follow guidance from their healthcare professionals regarding replacement therapy.

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