Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablet
Summary
The FDA issued a Class II for Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Bl by Mylan Institutional, Inc.. Reason: Super-Potent Drug: Out of specification potency results were obtained..
Details
Source
Drug Recall
External ID
D-0291-2025
Action Date
2025-03-26
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot 3115773, Exp. 03/31/2025
Quantity Affected: 1,068 cartons
Reason for Recall
Super-Potent Drug: Out of specification potency results were obtained.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-07
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 60 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-0291-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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