D-0119-2025 Class II Ongoing
FDA drug recall D-0119-2025 was initiated by Viatris Inc on Nov 18, 2024 and is designated Class II. Reason for recall: Superpotent Drug and Subpotent Drug: potency failures obtained The recall status is ongoing. Affected quantity: 118,324 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 18, 2024
- Initiation Date
- Nov 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118,324 bottles
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
Distribution Pattern
Nationwide within the United States and Puerto Rico
Code 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0119-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026