Levothyroxine Sodium Tablets Recalled for Subpotency Nationwide

Plain-English summary

Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), packaged in 10-tablet unit dose blisters per carton. The product was distributed nationwide in the USA and is packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, with distribution handled by Cardinal Health, Dublin, OH.

The recall is due to subpotent drug, meaning the tablets do not contain the expected amount of active ingredient. The affected lots include Bag lot numbers N02200A and N02200B with expiration date 10/2026, and Blister lot number N02200 with expiration date 10/2026. The NDC Bag is 55154-3559-0 and the NDC Blister is 0904-6950-61.

This is a Class II recall, which the FDA classifies as a situation where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where no adverse health consequences are likely to occur. No illnesses or injuries have been reported in connection with this recall.

Consumers taking Levothyroxine Sodium Tablets should check the lot numbers on their medication. If the product matches the recalled lots, they should return it to the pharmacy or distributor for a replacement or refund. Patients should not discontinue their medication without consulting their healthcare provider.

The recalled product

Product

LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)

Brand

LEVOTHYROXINE SODIUM

Manufacturer

Major Pharmaceuticals

Category

Drug — Prescription Levothyroxine Tablets

Hazard

• subpotent-drug
• dosage-potency

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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