FDA Drugs recall ·
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only… recall
- Recall number
- D-0291-2025
- Date
- (initiated March 7, 2025)
- Company / brand
- Mylan Institutional, Inc.
1718 Northrock Ct, Rockford, IL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,068 cartons
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Super-Potent Drug: Out of specification potency results were obtained.
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 3115773, Exp. 03/31/2025
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-0291-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.