Levothyroxine Sodium Tablet
FDA Recall NDC 55154-4309
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Levothyroxine Sodium (NDC 55154-4309). A significant event, classified as Class II, was initiated on Jul 13, 2026 by Cardinal Health 107, Llc. The reported reason for this action was: "Subpotent Drug"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Subpotent Drug
Jul 13, 2026
Jul 29, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99399
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Major Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61
Batch or Lot Expiration Information
Lot# Bag
Lot# : N02167A, Exp. Date 07/2026; Blister
Lot# N02167, Exp. Date 07/2026
Affected Packages Involved in this Recall
55154-3558-0Product
55154-3559-0Product
55154-3560-0Product
55154-4309-0Product
55154-3561-0Product
55154-3562-0Product
55154-3563-0Product
0904-6949-61Product
0904-6950-61Product
0904-6951-61Product
0904-6952-61Product
0904-6953-61Product
0904-6954-61Product
0904-6955-61Product
0904-6956-61Product
0904-6957-61Product
Class II Ongoing
Subpotent Drug
Jul 13, 2026
Jul 29, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99399
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Major Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61
Batch or Lot Expiration Information
Lot# Bag
Lot# : N02266A, N02266B, Exp. Date 11/2026; Blister
Lot# : N02266, Exp. Date 11/2026
Affected Packages Involved in this Recall
55154-3558-0Product
55154-3559-0Product
55154-3560-0Product
55154-4309-0Product
55154-3561-0Product
55154-3562-0Product
55154-3563-0Product
0904-6949-61Product
0904-6950-61Product
0904-6951-61Product
0904-6952-61Product
0904-6953-61Product
0904-6954-61Product
0904-6955-61Product
0904-6956-61Product
0904-6957-61Product
Class II Ongoing
Subpotent Drug
Jul 13, 2026
Jul 29, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99399
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Major Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61
Batch or Lot Expiration Information
Lot# Bag
Lot# : N02172A, N02172B, Exp. Date 07/2026; N02288A, N02288B, Exp. Date 12/2026; Blister
Lot# : N02172, Exp. Date 07/2026; N02288, Exp. Date 12/2026
Affected Packages Involved in this Recall
55154-3558-0Product
55154-3559-0Product
55154-3560-0Product
55154-4309-0Product
55154-3561-0Product
55154-3562-0Product
55154-3563-0Product
0904-6949-61Product
0904-6950-61Product
0904-6951-61Product
0904-6952-61Product
0904-6953-61Product
0904-6954-61Product
0904-6955-61Product
0904-6956-61Product
0904-6957-61Product
Class II Ongoing
Subpotent Drug
Jul 13, 2026
Jul 29, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99399
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Major Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Carton: 55154-3558-0; NDC Blister: 0904-6949-61
Batch or Lot Expiration Information
Lot# Bag
Lot# : N02212A, N02212B, Exp. Date 07/2026; Blister
Lot# : N02212, Exp. Date 07/2026
Affected Packages Involved in this Recall
55154-3558-0Product
55154-3559-0Product
55154-3560-0Product
55154-4309-0Product
55154-3561-0Product
55154-3562-0Product
55154-3563-0Product
0904-6949-61Product
0904-6950-61Product
0904-6951-61Product
0904-6952-61Product
0904-6953-61Product
0904-6954-61Product
0904-6955-61Product
0904-6956-61Product
0904-6957-61Product
Class II Ongoing
Subpotent Drug
Jul 13, 2026
Jul 29, 2026
N/A
Recall Profile & Regulatory Data
Event ID
99399
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Major Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3559-0; NDC Blister: 0904-6950-61
Batch or Lot Expiration Information
Lot# Bag
Lot# : N02200A, N02200B, Exp. Date 10/2026; Blister
Lot# : N02200, Exp. Date 10/2026
Affected Packages Involved in this Recall
55154-3558-0Product
55154-3559-0Product
55154-3560-0Product
55154-4309-0Product
55154-3561-0Product
55154-3562-0Product
55154-3563-0Product
0904-6949-61Product
0904-6950-61Product
0904-6951-61Product
0904-6952-61Product
0904-6953-61Product
0904-6954-61Product
0904-6955-61Product
0904-6956-61Product
0904-6957-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
