FDA Recall D-0521-2025

ACCORD HEALTHCARE, INC. · Raleigh, NC

Class II Ongoing 328 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

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

Quantity: 9,739 bottles

Reason for recall

Subpotent Drug: Assay below the approved specification

Recall record

Recall number: D-0521-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-06-20
Classified by FDA Center: 2025-07-14
FDA published: 2025-07-23
Recalling firm: ACCORD HEALTHCARE, INC.
Firm location: Raleigh, NC

Drug identification

Brand name(s): LEVOTHYROXINE SODIUM
Generic name(s): LEVOTHYROXINE SODIUM
Manufacturer(s): Accord Healthcare Inc.
NDC(s): 16729-447, 16729-458, 16729-448, 16729-449, 16729-451, 16729-450, 16729-452, 16729-453, 16729-454, 16729-455, 16729-456, 16729-457
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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