Levothyroxine Sodium Tablet
FDA Recall NDC 0378-1821

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 12 recorded enforcement report(s) associated with Levothyroxine Sodium (NDC 0378-1821). A significant event, classified as Class II, was initiated on Nov 18, 2024 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Superpotent Drug and Subpotent Drug: potency failures obtained"

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-0128-2025ONGOINGD-0119-2025ONGOINGD-0123-2025ONGOINGD-0121-2025ONGOINGD-0122-2025ONGOINGD-0124-2025ONGOINGD-0126-2025ONGOINGD-0125-2025ONGOINGD-0120-2025ONGOINGD-0127-2025ONGOINGD-0118-2025ONGOINGD-0526-2021TERMINATED

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0128-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
35,883 bottles

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 8171623, Exp. Date Feb 2025; 8164486, Exp. Date Nov 2024 b)3205462, Exp. Date Aug 2025; 3192428, Exp. Date Feb 2025; 3184096, Exp. Date Nov 2024
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0119-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
118,324 bottles

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 8165919, Exp. Date Dec 2024; 8172050, Exp. Date Mar 2025; 8183251, Exp. Date Sept 2025 b) 3185542, Exp. date Dec 2024; 3192838, Exp. Date Mar 2025; 3208172, Exp. Date Sept 2025
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0123-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
34,845 bottes

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 8181875, Exp. Date Aug 2025; 8174497, Exp. Date April 2025 b) 3209099, Exp. Date Sep 2025; 3206534, Exp. Date Aug 2025; 3196137, Exp. Date April 2025
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0121-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
19, 549 bottles

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 3192915, 8172108, Exp. Date Mar 2025; b) 3208680, Exp. Date Sep 2025
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0122-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
55,032 bottles

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a)8179847, Exp. Date July 2025; b) 3203518, Exp. Date July 2025
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0124-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
42,331 bottles

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 8174701, Exp. Date April 2025; 8182228, Exp. Date Aug 2025 b)3193984, Exp. Date Mar 2025; 3206790, Exp. Date Aug 2025
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0126-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
43,765 bottles

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# a) 8180781, Exp. Date Aug 2025; b)3191628, Exp. Date Feb 2025; 3197139, Exp. Date Apr 2025; 3188976, Exp. Date Jan 2025; 3184929, Exp. Date Dec 2024; 3204909, Exp. Date Aug 2025
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0125-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
63,077 bottles

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 8177078, Exp. Date May 2025; 8168596, Exp. Date Jan 2025 b) 3199313, Exp. Date May 2025; 3194118, Exp. Date Mar 2025; 3186238, Exp. Date Dec 2024; 3209590, Exp. Date Sep 2025; 3199317, Exp. Date May 2025; 3188733, Exp. Date Jan 2025
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0120-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
9,828 bottles

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 8177720, Exp. Date Jun 2025; b) 3200218, Exp. Date Jun 2025
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0127-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
65,169

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 8171269, Exp. Date Feb 2025; 8179579, Exp. Date July 2025 b)3183815, Exp. Date Nov 2024; 3189147, Exp. Date Jan 2025; 3192027, Exp. Date Feb 2025; 3202894, Exp. Date Jul 2025; 3192026, Exp. Date Feb 2025; 3199781, Exp. Date Jun 2025. 3192028, exp. date Feb 2025 3202895, exp. date July 2025
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

November 2024 Class II Recall: Superpotent Drug and Subpotent Drug

Recall Number
D-0118-2025
Class II Ongoing
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Initiated
Nov 18, 2024
Reported
Dec 18, 2024
Quantity
92,512 bottles

Recall Profile & Regulatory Data

Event ID
95768
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Viatris Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and Puerto Rico
Product Description
Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# : a) 3182797, Exp. Date Nov 2024; 8177587, b) 3199816, Exp. Date Jun 2025
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

March 2021 Class II Recall: CGMP Deviations

Recall Number
D-0526-2021
Class II Terminated
Reason for Recall
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Initiated
Mar 15, 2021
Reported
Jun 02, 2021
Quantity
112 bottles

Recall Profile & Regulatory Data

Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Batch or Lot Expiration Information
Lot# 3109046
Affected Packages Involved in this Recall
0378-1800-77Product
0378-1800-10Product
0378-1803-77Product
0378-1803-10Product
0378-1805-77Product
0378-1805-10Product
0378-1807-77Product
0378-1807-10Product
0378-1809-77Product
0378-1809-10Product
0378-1811-77Product
0378-1811-10Product
0378-1813-77Product
0378-1813-10Product
0378-1823-77Product
0378-1823-10Product
0378-1815-77Product
0378-1815-10Product
0378-1817-77Product
0378-1817-10Product
0378-1819-77Product
0378-1819-10Product
0378-1821-77Product

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.