← FDA ENFORCEMENT
D-0785-2026Class 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
2026-09-02
Distribution
Nationwide within the United States
Firm state
NC
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent Drug

Product description

Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.

Code / lot info

a) Lot # D2402430, D2402431, Exp Date: 10/31/2026. b) Lot #: D2402432, Exp. Date 10/31/2026; D2500180, Exp. Date 12/31/2026.

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 →