Recalling firm
Mylan Institutional, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-03-26
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
1,068 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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.
Code / lot info
Lot 3115773, Exp. 03/31/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.