Levothyroxine Sodium Tablets recall
FDA recall D-0523-2025 · initiated Jun 20, 2025
ACCORD HEALTHCARE, INC. recalled Levothyroxine Sodium Tablets in Jun 2025 — an FDA Class II recall (D-0523-2025) because Subpotent Drug: Assay below the approved specification.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug: Assay below the approved specification
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: 4,921 bottles
Details
- Product
- Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17
- Recalling company
- ACCORD HEALTHCARE, INC.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 20, 2025
- FDA report date
- Jul 23, 2025
Frequently asked
- Was Levothyroxine Sodium Tablets recalled?
- ACCORD HEALTHCARE, INC. recalled Levothyroxine Sodium Tablets in Jun 2025 — an FDA Class II recall (D-0523-2025) because Subpotent Drug: Assay below the approved specification. 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-0523-2025 was: Subpotent Drug: Assay below the approved specification
- 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 in the USA. The recall covers these lots — Lot #D2300076, Exp Date: 12/31/2025. 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-0523-2025.