Levothyroxine Sodium Tablets USP 150 mcg recall
FDA recall D-0403-2026 · initiated Feb 26, 2026
MACLEODS PHARMA USA, INC recalled Levothyroxine Sodium Tablets USP 150 mcg in Feb 2026 — an FDA Class II recall (D-0403-2026) because Subpotent Drug.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent 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: 1315 bottles
Details
- Product
- Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44
- Recalling company
- Macleods Pharms Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Feb 26, 2026
- FDA report date
- Apr 1, 2026
Frequently asked
- Was Levothyroxine Sodium Tablets USP 150 mcg recalled?
- MACLEODS PHARMA USA, INC recalled Levothyroxine Sodium Tablets USP 150 mcg in Feb 2026 — an FDA Class II recall (D-0403-2026) because Subpotent Drug. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Levothyroxine Sodium Tablets USP 150 mcg recalled?
- Per the FDA enforcement record, the reason for recall D-0403-2026 was: Subpotent Drug
- Is a recalled Levothyroxine Sodium Tablets USP 150 mcg 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 150 mcg are affected?
- Distributed: Nationwide. The recall covers these lots — Lot 16240062A, exp date 3/2026. 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-0403-2026.