ACCORD HEALTHCARE, INC.: Drug Recall

Recall #D-0006-2026 · 09/16/2025

Class II: Risk

Recall Details

Recall Number
D-0006-2026
Classification
Class II
Product Type
Drug
Recalling Firm
ACCORD HEALTHCARE, INC.
Status
Ongoing
Date Initiated
09/16/2025
Location
Raleigh, NC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
54,432 bottles

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.

Product Description

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.

Distribution Pattern

Nationwide in the US

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.