FDA Recall D-0259-2026

Alvogen, Inc · Morristown, NJ

Class II Ongoing 134 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, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.

Lot / code: Lot # MHA21825, Exp Date: December 31, 2027

Reason for recall

Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.

Recall record

Recall number: D-0259-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2025-12-31
Classified by FDA Center: 2026-01-14
FDA published: 2026-01-21
Recalling firm: Alvogen, Inc
Firm location: Morristown, NJ

Drug identification

Brand name(s): LEVOTHYROXINE SODIUM
Generic name(s): LEVOTHYROXINE SODIUM
Manufacturer(s): Alvogen, Inc.
NDC(s): 47781-640, 47781-643, 47781-646, 47781-649, 47781-651, 47781-654, 47781-657, 47781-659, 47781-662, 47781-665, 47781-668, 47781-671
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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