Levothyroxine Sodium Tablets recall
FDA recall D-0131-2025 · initiated Nov 19, 2024
Mylan Institutional, Inc. recalled Levothyroxine Sodium Tablets in Nov 2024 — an FDA Class II recall (D-0131-2025) because Subpotent and Superpotent Drug.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent and Superpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,835 cartons
Details
- 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
- Recalling company
- Mylan Institutional
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA.
- Initiated
- Nov 19, 2024
- FDA report date
- Dec 18, 2024
Frequently asked
- Was Levothyroxine Sodium Tablets recalled?
- Mylan Institutional, Inc. recalled Levothyroxine Sodium Tablets in Nov 2024 — an FDA Class II recall (D-0131-2025) because Subpotent and Superpotent Drug. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Levothyroxine Sodium Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0131-2025 was: Subpotent and Superpotent Drug
- Is a recalled Levothyroxine Sodium Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Levothyroxine Sodium Tablets are affected?
- Distributed: Nationwide in the USA.. The recall covers these lots — Lot #: 3115936, Exp. Date 07/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0131-2025.