← FDA ENFORCEMENT
D-0395-2025Class II

ACCORD HEALTHCARE, INC.

Recalling firm
ACCORD HEALTHCARE, INC.
Product type
Drug
Status
Ongoing
Report date
2025-05-07
Distribution
Nationwide US.
Firm state
NC
Product quantity
4,872 Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent

Product description

Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.

Code / lot info

Lot # D2400547, Exp Date: 02/2026

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. 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.