D-0521-2025 Class II Ongoing

Recalled by ACCORD HEALTHCARE, INC. — Raleigh, NC

Recall Details

Product Type
Drugs
Report Date
July 23, 2025
Initiation Date
June 20, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,739 bottles

Product Description

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 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 16729-451-17

Reason for Recall

Subpotent Drug: Assay below the approved specification

Distribution Pattern

Nationwide in the USA

Code Information

Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026