Class IIReported 2025-07-23

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

Recalled by ACCORD HEALTHCARE, INC.

Reason for Recall

Subpotent Drug: Assay below the approved specification

Recall Number

D-0521-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-06-20

Reported

2025-07-23

Distribution

Nationwide in the USA

Code Info

Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.