Mylan Institutional, Inc.: Drug Recall

Recall #D-0291-2025 · 03/07/2025

Class II: Risk

Recall Details

Recall Number
D-0291-2025
Classification
Class II
Product Type
Drug
Recalling Firm
Mylan Institutional, Inc.
Status
Ongoing
Date Initiated
03/07/2025
Location
Rockford, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,068 cartons

Reason for Recall

Super-Potent Drug: Out of specification potency results were obtained.

Product Description

Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 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 51079-443-20.

Distribution Pattern

Nationwide in the USA

Other Recalls by Mylan Institutional, Inc.

View all recalls by Mylan Institutional, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.