ACCORD HEALTHCARE, INC.: Drug Recall

Recall #D-0521-2025 · 06/20/2025

Class II: Risk

Recall Details

Recall Number: D-0521-2025
Classification: Class II
Product Type: Drug
Recalling Firm: ACCORD HEALTHCARE, INC.
Status: Ongoing
Date Initiated: 06/20/2025
Location: Raleigh, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,739 bottles

Reason for Recall

Subpotent Drug: Assay below the approved specification

Product Description

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 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 16729-451-17

Distribution Pattern

Nationwide in the USA

Other Recalls by ACCORD HEALTHCARE, INC.

Class II: Risk 09/16/2025

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification

View all recalls by ACCORD HEALTHCARE, INC. →

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.