Why was Levothyroxine Sodium Tablets recalled?

Per the FDA enforcement record, the reason for recall D-0076-2025 was: Subpotent drug

Which lots of Levothyroxine Sodium Tablets are affected?

Distributed: USA Nationwide. The recall covers these lots — Lot #: D2300191, Exp 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-0076-2025.

Class IIOngoing

Levothyroxine Sodium Tablets recall

FDA recall D-0076-2025 · initiated Nov 8, 2024

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Dec 11, 2024How we research

ACCORD HEALTHCARE, INC. recalled Levothyroxine Sodium Tablets in Nov 2024 — an FDA Class II recall (D-0076-2025) 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.

Lot #: D2300191, Exp 12/31/2025

Details

Product: Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
Recalling company: ACCORD HEALTHCARE, INC.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide
Initiated: Nov 8, 2024
FDA report date: Dec 11, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was Levothyroxine Sodium Tablets recalled?: ACCORD HEALTHCARE, INC. recalled Levothyroxine Sodium Tablets in Nov 2024 — an FDA Class II recall (D-0076-2025) because Subpotent drug. 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-0076-2025 was: Subpotent drug
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: USA Nationwide. The recall covers these lots — Lot #: D2300191, Exp 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-0076-2025.

Source: openFDA Drug Enforcement record D-0076-2025 ↗

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