Drug FDA Class II Ongoing Sub/super-potent
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 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: 51079-443-20
Mylan Institutional, Inc. Published Dec 18, 2024
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Mylan Institutional, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Subpotent and Superpotent Drug
Hazards
Subpotency and Superpotency · primary
Affected products (1)
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 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: 51079-443-20
LEVOTHYROXINE SODIUM · 1,664 cartons
NDC: 51079-440, 51079-444, 51079-441, 51079-442, 51079-443, 51079-445, 51079-440-01, 51079-440-20, 51079-444-01, 51079-444-20, 51079-441-01, 51079-441-20, 51079-442-01, 51079-442-20, 51079-443-01, 51079-443-20, 51079-445-01, 51079-445-20
Code info: Lot #: 3115893, Exp. Date 6/2025
Affected areas
Nationwide
Timeline
- InitiatedNov 19, 2024
- PublishedDec 18, 2024
- Recall number
- D-0133-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.