FDA Recall D-0006-2026

ACCORD HEALTHCARE, INC. · Raleigh, NC

Class II Ongoing 240 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, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.

Lot / code: Lot # D2300045, Exp 12/31/2025.

Quantity: 54,432 bottles

Reason for recall

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

Recall record

Recall number: D-0006-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2025-09-16
Classified by FDA Center: 2025-10-06
FDA published: 2025-10-15
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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