Levothyroxine Sodium Tablets recall
FDA recall D-0394-2025 · initiated Apr 10, 2025
ACCORD HEALTHCARE, INC. recalled Levothyroxine Sodium Tablets in Apr 2025 — an FDA Class II recall (D-0394-2025) because Subpotent.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent
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: 4,888 Bottles
Details
- Product
- Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17
- Recalling company
- ACCORD HEALTHCARE, INC.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide US.
- Initiated
- Apr 10, 2025
- FDA report date
- May 7, 2025
Frequently asked
- Was Levothyroxine Sodium Tablets recalled?
- ACCORD HEALTHCARE, INC. recalled Levothyroxine Sodium Tablets in Apr 2025 — an FDA Class II recall (D-0394-2025) because Subpotent. 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-0394-2025 was: Subpotent
- 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 US.. The recall covers these lots — Lot # D2300323, Exp Date: 01/2026. 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-0394-2025.