Class IIOngoing

Levothyroxine Sodium Tablets recall

FDA recall D-0006-2026 · initiated Sep 16, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

Details

Product: Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
Recalling company: ACCORD HEALTHCARE, INC.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the US
Initiated: Sep 16, 2025
FDA report date: Oct 15, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0006-2026 ↗

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