Levothyroxine Sodium Tablets recall
FDA recall D-0167-2025 · initiated Dec 20, 2024
Lupin Pharmaceuticals Inc. recalled Levothyroxine Sodium Tablets in Dec 2024 — an FDA Class II recall (D-0167-2025) because Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
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: 480 1000-count bottles
Details
- Product
- Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- One US distributor in Ohio.
- Initiated
- Dec 20, 2024
- FDA report date
- Jan 8, 2025
This recall is linked to a product we cover: Levothyroxine Sodium →
Frequently asked
- Was Levothyroxine Sodium Tablets recalled?
- Lupin Pharmaceuticals Inc. recalled Levothyroxine Sodium Tablets in Dec 2024 — an FDA Class II recall (D-0167-2025) because Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study. 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-0167-2025 was: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
- 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: One US distributor in Ohio.. The recall covers these lots — Lot# LA01276, Exp Date: 07/2026. 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-0167-2025.