FDA recall D-0519-2025

ACCORD HEALTHCARE, INC. · Class II · drug

Product

Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 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 16729-447-17

Reason for recall

Subpotent Drug: Assay below the approved specification

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-06-20
Report date: 2025-07-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Raleigh, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2025