Class II

Drug Recall: Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Ro

ACCORD HEALTHCARE, INC. · June 20, 2025

Reason for Recall

Subpotent Drug: Assay below the approved specification

Product Description

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

4,896 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0522-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.