Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufacture...
FDA Recall #D-0006-2026 — Class II — September 16, 2025
Product Description
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.
Reason for Recall
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Recalling Firm
ACCORD HEALTHCARE, INC. — Raleigh, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
54,432 bottles
Distribution
Nationwide in the US
Code Information
Lot # D2300045, Exp 12/31/2025.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated