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- FDA Recall: Levothyroxine Sodium
FDA Recall Levothyroxine Sodium
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on November 18th, 2024 and classified as a Class II recall due to superpotent drug and subpotent drug: potency failures obtained This recall is currently ongoing, and the associated recall number is recall number is D-0128-2025. It pertains to Levothyroxine Sodium identified by 0378-1823.
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0128-2025 | 11-18-2024 | 12-18-2024 | 35,883 bottles | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0119-2025 | 11-18-2024 | 12-18-2024 | 118,324 bottles | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0122-2025 | 11-18-2024 | 12-18-2024 | 55,032 bottles | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0123-2025 | 11-18-2024 | 12-18-2024 | 34,845 bottes | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0126-2025 | 11-18-2024 | 12-18-2024 | 43,765 bottles | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0125-2025 | 11-18-2024 | 12-18-2024 | 63,077 bottles | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0124-2025 | 11-18-2024 | 12-18-2024 | 42,331 bottles | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0127-2025 | 11-18-2024 | 12-18-2024 | 65,169 | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0121-2025 | 11-18-2024 | 12-18-2024 | 19, 549 bottles | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0120-2025 | 11-18-2024 | 12-18-2024 | 9,828 bottles | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0118-2025 | 11-18-2024 | 12-18-2024 | 92,512 bottles | 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. | Superpotent Drug and Subpotent Drug: potency failures obtained | Ongoing |
| D-0526-2021 | 03-15-2021 | 06-02-2021 | 112 bottles | 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. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
Recall Enforcement Report D-0128-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0128-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 35,883 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- 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 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0119-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0119-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 118,324 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- 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 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0122-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0122-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 55,032 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- Lot #: a)8179847, Exp. Date July 2025; b) 3203518, Exp. Date July 2025 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0123-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0123-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 34,845 bottes Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- 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 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0126-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0126-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 43,765 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- 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 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0125-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0125-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 63,077 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- 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 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0124-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0124-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 42,331 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- Lot #: a) 8174701, Exp. Date April 2025; 8182228, Exp. Date Aug 2025 b)3193984, Exp. Date Mar 2025; 3206790, Exp. Date Aug 2025 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0127-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0127-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 65,169 Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- 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 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0121-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0121-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 19, 549 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- Lot #: a) 3192915, 8172108, Exp. Date Mar 2025; b) 3208680, Exp. Date Sep 2025 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0120-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0120-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 9,828 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- Lot #: a) 8177720, Exp. Date Jun 2025; b) 3200218, Exp. Date Jun 2025 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0118-2025
- Event ID
- 95768 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0118-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- Nationwide within the United States and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- Superpotent Drug and Subpotent Drug: potency failures obtained What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 92,512 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 12-18-2024
- Recall Initiation Date
- 11-18-2024 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Viatris Inc
- Code Info
- Lot #: a) 3182797, Exp. Date Nov 2024; 8177587, b) 3199816, Exp. Date Jun 2025 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Ongoing
Recall Enforcement Report D-0526-2021
- Event ID
- 87512 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). - Recall Number
- D-0526-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). - Recall Classification
- Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". - Distribution Pattern
- FL, GA, SC What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. - 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.
- Reason For Recall
- CGMP Deviations: Intermittent exposure to temperature excursion during storage. What is the Reason for Recall?
Information describing how the product is defective. - Product Quantity
- 112 bottles Product Quantity
The amount of product subject to recall. - Voluntary Mandated
- Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. - Report Date
- 06-02-2021
- Recall Initiation Date
- 03-15-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. - Termination Date
- 06-17-2024 What is the Date Terminated?
The date that FDA terminated the recall. - Initial Firm Notification
- Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. - Product Type
- Drugs
- Recalling Firm
- Cardinal Health Inc.
- Code Info
- 3109046 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. - Recalled NDC Packages
- 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77
- Status
- Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
