FDA recall D-0006-2026

ACCORD HEALTHCARE, INC. · Class II · drug

Product

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.

Reason for recall

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

Distribution

Nationwide in the US

Key facts

Status
Ongoing
Initiation date
2025-09-16
Report date
2025-10-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raleigh, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0006-2026