FDA recall D-0396-2025

Product

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17

Reason for recall

Subpotent

Distribution

Nationwide US.

Key facts

Status

Ongoing

Initiation date

2025-04-10

Report date

2025-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Raleigh, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0396-2025