D-0290-2025 Class II Ongoing
FDA drug recall D-0290-2025 was initiated by Mylan Institutional, Inc. on Mar 7, 2025 and is designated Class II. Reason for recall: Super-Potent Drug: Out of specification potency results were obtained. The recall status is ongoing. Affected quantity: 347 Cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 26, 2025
- Initiation Date
- Mar 7, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 347 Cartons
Product Description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.
Reason for Recall
Super-Potent Drug: Out of specification potency results were obtained.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 3116074, Exp. 09/30/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0290-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026