Humco Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels
Humco Holding Group, Inc. is recalling 10 kilograms of Thyroid, USP powder because it has inconsistent levels of levothyroxine and liothyronine.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation regarding ingredient consistency rather than a confirmed acute injury or high-risk pathogen.
Plain-English summary
Humco Holding Group, Inc. is recalling 10 kilograms of Thyroid, USP (Full Strength) powder. The product is an active pharmaceutical ingredient containing levothyroxine and liothyronine, packaged in 1000-gram units under NDC 0395-6580-43. The specific lot affected is A26450, with an expiration date of 05/2019.
The recall was initiated after the supplier reported Current Good Manufacturing Practice (CGMP) deviations. Specifically, the Thyroid Powder was found to have inconsistent levels of the active ingredients levothyroxine and liothyronine. The product was distributed nationwide.
This recall involves a raw pharmaceutical ingredient intended for further manufacturing, not a finished medication for direct consumer use. Healthcare providers and manufacturers should stop using the affected lot and contact Humco Holding Group, Inc. for instructions on return or disposal.
The recalled product
- Product
- Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-6580-43 Packaged by: Humco Texarkana, TX 75501 USA
- Manufacturer
- Humco Holding Group, Inc
- Category
- Drug — Pharmaceutical Ingredient
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: A26450 Exp. 05/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Humco Holding Group, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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