US Drug Recall Register
Class III · Low risk Ongoing Initiated May 29, 2025 (15 months ago)

Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Presence of a foreign substance: black hair found embedded in tablet.

What was recalled

Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.

Recalling firm
Macleods Pharmaceuticals Ltd
NDC code
33342-398-44
Origin
India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0470-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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