Levothyroxine Sodium Tablets recall
FDA recall D-0470-2025 · initiated May 29, 2025
Macleods Pharmaceuticals Ltd recalled Levothyroxine Sodium Tablets in May 2025 — an FDA Class III recall (D-0470-2025) because Presence of a foreign substance: black hair found embedded in tablet.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Presence of a foreign substance: black hair found embedded in tablet.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 1,344- 1000 count bottles
Details
- Product
- Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
- Recalling company
- Macleods Pharms Ltd
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 29, 2025
- FDA report date
- Jun 18, 2025
Frequently asked
- Was Levothyroxine Sodium Tablets recalled?
- Macleods Pharmaceuticals Ltd recalled Levothyroxine Sodium Tablets in May 2025 — an FDA Class III recall (D-0470-2025) because Presence of a foreign substance: black hair found embedded in tablet. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Levothyroxine Sodium Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0470-2025 was: Presence of a foreign substance: black hair found embedded in tablet.
- 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. 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 #: MLF2401A, Exp 01/31/2026. 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-0470-2025.