FDA Drugs recall ·

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg)… recall

Recall number
D-0131-2025
Date
(initiated November 19, 2024)
Company / brand
Mylan Institutional, Inc.
1718 Northrock Ct, Rockford, IL, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
2,835 cartons
Hazard tags
Potency
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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

Why was it recalled?

Subpotent and Superpotent Drug

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot #: 3115936, Exp. Date 07/2025

Distribution

Nationwide in the USA.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0131-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.