FDA recall D-0785-2026

ACCORD HEALTHCARE, INC. · Class II · drug

Product

Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.

Reason for recall

Subpotent Drug

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2026-08-06
Report date
2026-09-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raleigh, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0785-2026