Levothyroxine Sodium Tablets USP recall
FDA recall D-0125-2025 · initiated Nov 18, 2024
Viatris Inc recalled Levothyroxine Sodium Tablets USP in Nov 2024 — an FDA Class II recall (D-0125-2025) because Superpotent Drug and Subpotent Drug: potency failures obtained.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Superpotent Drug and Subpotent Drug: potency failures obtained
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: 63,077 bottles
Details
- Product
- Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Recalling company
- Viatris
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States and Puerto Rico
- Initiated
- Nov 18, 2024
- FDA report date
- Dec 18, 2024
Frequently asked
- Was Levothyroxine Sodium Tablets USP recalled?
- Viatris Inc recalled Levothyroxine Sodium Tablets USP in Nov 2024 — an FDA Class II recall (D-0125-2025) because Superpotent Drug and Subpotent Drug: potency failures obtained. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Levothyroxine Sodium Tablets USP recalled?
- Per the FDA enforcement record, the reason for recall D-0125-2025 was: Superpotent Drug and Subpotent Drug: potency failures obtained
- Is a recalled Levothyroxine Sodium Tablets USP 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 USP are affected?
- Distributed: Nationwide within the United States and Puerto Rico. The recall covers these lots — Lot #: a) 8177078, Exp. Date May 2025; 8168596, Exp. Date Jan 2025 b) 3199313, Exp. Date May 2025; 3194118, Exp. Date Mar 2025; 3186238, Exp. Date Dec 2024; 3209590, Exp. Date Sep 2025; 3199317, Exp. Date May 2025; 3188733, Exp. Date Jan 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-0125-2025.