← FDA ENFORCEMENT
D-0522-2025Class II

ACCORD HEALTHCARE, INC.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
ACCORD HEALTHCARE, INC.
Product type
Drug
Status
Ongoing
Report date
2025-07-23
Distribution
Nationwide in the USA
Firm state
NC
Product quantity
4,896 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent Drug: Assay below the approved specification

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →