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Class II · Moderate risk Terminated Initiated Aug 28, 2018 (8 years ago)

Thyroid

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA

Affected NDC 0395-8077-62

Compare with the code on your package — it is the most precise check available.

Drug: Levothyroxine Category: Thyroid Medication

Recalling firm
Humco Holding Group, Inc
NDC code
0395-8077-62
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0023-2019 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Levothyroxine recalls

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Other recalls by Humco Holding Group, Inc

All 2018 recalls
Class II · Moderate risk

Thyroid

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Terminated cGMP deviation Humco Holding Group, Inc NDC 0395-6580-43 D-0024-2019
Class II · Moderate risk

Thyroid

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Terminated cGMP deviation Humco Holding Group, Inc NDC 0395-8077-43 D-0022-2019