Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets
Summary
The FDA issued a Class II for Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (1 by Mylan Institutional, Inc.. Reason: Subpotent and Superpotent Drug.
Details
Source
Drug Recall
External ID
D-0135-2025
Action Date
2024-12-18
Status
Ongoing
Category
drug
Product Description
Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 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: 51079-445-20
Lot/Code Info: Lot #: 3115924, Exp. Date 06/2025
Quantity Affected: 690 cartons
Reason for Recall
Subpotent and Superpotent Drug
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-19
Company
Rockford, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 105 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Mylan Institutional, Inc. has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mylan Institutional, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mylan Institutional, Inc. have FDA actions?
Mylan Institutional, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0135-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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