Home / Recalls / ACCORD HEALTHCARE, INC. / D-0522-2025

D-0522-2025 Class II Ongoing

Recalled by ACCORD HEALTHCARE, INC. — Raleigh, NC

Recall Details

Product Type: Drugs
Report Date: July 23, 2025
Initiation Date: June 20, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,896 bottles

Product Description

Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 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 16729-452-17

Reason for Recall

Subpotent Drug: Assay below the approved specification

Distribution Pattern

Nationwide in the USA

Code Information

Lot #D2300104, Exp Date: 12/31/2025

Other recalls by ACCORD HEALTHCARE, INC.

D-0006-2026 Class II — Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx (September 16, 2025)
D-0523-2025 Class II — Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only (June 20, 2025)
D-0519-2025 Class II — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only (June 20, 2025)
D-0524-2025 Class II — Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Onl (June 20, 2025)
D-0520-2025 Class II — Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, M (June 20, 2025)
D-0521-2025 Class II — Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, (June 20, 2025)
D-0518-2025 Class II — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, (June 20, 2025)
D-0395-2025 Class II — Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manu (April 10, 2025)
D-0394-2025 Class II — Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Man (April 10, 2025)
D-0396-2025 Class II — Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Man (April 10, 2025)