Levothyroxine Sodium Tablet
FDA Recall NDC 16729-451
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 13 recorded enforcement report(s) associated with Levothyroxine Sodium (NDC 16729-451). A significant event, classified as Class II, was initiated on Sep 16, 2025 by Accord Healthcare Inc.. The reported reason for this action was: "Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range."
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
D-0006-2026D-0523-2025D-0518-2025D-0524-2025D-0521-2025D-0520-2025D-0519-2025D-0522-2025D-0396-2025D-0397-2025D-0395-2025D-0394-2025D-0076-2025
Class II Ongoing
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Sep 16, 2025
Oct 15, 2025
54,432 bottles
Recall Profile & Regulatory Data
Event ID
97613
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Product Description
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.
Batch or Lot Expiration Information
Lot# D2300045, Exp 12/31/2025.
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent Drug: Assay below the approved specification
Jun 20, 2025
Jul 23, 2025
4,921 bottles
Recall Profile & Regulatory Data
Event ID
97103
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 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 16729-455-17
Batch or Lot Expiration Information
Lot# D2300076, Exp Date: 12/31/2025
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent Drug: Assay below the approved specification
Jun 20, 2025
Jul 23, 2025
82,159 bottles
Recall Profile & Regulatory Data
Event ID
97103
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-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 16729-447-15
Batch or Lot Expiration Information
Lot# D2300325, Exp Date: 01/31/2026
Lot# D2400536, Exp Date: 02/28/2026
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent Drug: Assay below the approved specification
Jun 20, 2025
Jul 23, 2025
2,344 bottles
Recall Profile & Regulatory Data
Event ID
97103
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 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 16729-456-17
Batch or Lot Expiration Information
Lot# D2300042, Exp Date: 12/31/2025
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent Drug: Assay below the approved specification
Jun 20, 2025
Jul 23, 2025
9,739 bottles
Recall Profile & Regulatory Data
Event ID
97103
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Batch or Lot Expiration Information
Lot# D2300092, Exp Date: 12/31/2025
Lot# D2400722, Exp Date: 03/31/2026
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent Drug: Assay below the approved specification
Jun 20, 2025
Jul 23, 2025
54,227 bottles
Recall Profile & Regulatory Data
Event ID
97103
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-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 16729-448-15
Batch or Lot Expiration Information
Lot# D2300087, Exp Date: 12/31/2025
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent Drug: Assay below the approved specification
Jun 20, 2025
Jul 23, 2025
2,352 bottles
Recall Profile & Regulatory Data
Event ID
97103
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 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 16729-447-17
Batch or Lot Expiration Information
Lot# D2400679, Exp Date: 02/28/2026
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent Drug: Assay below the approved specification
Jun 20, 2025
Jul 23, 2025
4,896 bottles
Recall Profile & Regulatory Data
Event ID
97103
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 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 16729-452-17
Batch or Lot Expiration Information
Lot# D2300104, Exp Date: 12/31/2025
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent
Apr 10, 2025
May 07, 2025
4,885 Bottles
Recall Profile & Regulatory Data
Event ID
96666
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide US.
Product Description
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17
Batch or Lot Expiration Information
Lot# D2300044, Exp Date: 12/2025
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent
Apr 10, 2025
May 07, 2025
18,984 Bottles
Recall Profile & Regulatory Data
Event ID
96666
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide US.
Product Description
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15
Batch or Lot Expiration Information
Lot# D2400725, Exp Date: 03/2026
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent
Apr 10, 2025
May 07, 2025
4,872 Bottles
Recall Profile & Regulatory Data
Event ID
96666
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide US.
Product Description
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.
Batch or Lot Expiration Information
Lot# D2400547, Exp Date: 02/2026
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent
Apr 10, 2025
May 07, 2025
4,888 Bottles
Recall Profile & Regulatory Data
Event ID
96666
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide US.
Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17
Batch or Lot Expiration Information
Lot# D2300323, Exp Date: 01/2026
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
Class II Ongoing
Subpotent drug
Nov 08, 2024
Dec 11, 2024
N/A
Recall Profile & Regulatory Data
Event ID
95747
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
Batch or Lot Expiration Information
Lot# : D2300191, Exp 12/31/2025
Affected Packages Involved in this Recall
16729-458-15Product
16729-458-17Product
16729-447-15Product
16729-447-17Product
16729-448-15Product
16729-448-17Product
16729-449-15Product
16729-449-17Product
16729-451-15Product
16729-451-17Product
16729-450-15Product
16729-450-17Product
16729-452-15Product
16729-452-17Product
16729-453-15Product
16729-453-17Product
16729-454-15Product
16729-454-17Product
16729-455-15Product
16729-455-17Product
16729-456-15Product
16729-456-17Product
16729-457-15Product
16729-457-17Product
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.
