← FDA ENFORCEMENT
D-0131-2025Class II

Mylan Institutional, Inc.

Recalling firm
Mylan Institutional, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-12-18
Distribution
Nationwide in the USA.
Firm state
IL
Product quantity
2,835 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Subpotent and Superpotent Drug

Product description

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-20

Code / lot info

Lot #: 3115936, Exp. Date 07/2025

Other recalls SPEQ maps to Validation & Qualification
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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.