The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0023-2019·Announced 2018-10-24

Humco Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

Humco Holding Group, Inc. is recalling Thyroid, USP (Porcine) 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 temporary or medically reversible adverse health consequence. The source cites CGMP deviations regarding inconsistent active ingredient levels without reporting specific injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Humco Holding Group, Inc. is recalling Thyroid, USP (Porcine) powder, an active pharmaceutical ingredient packaged in 100-gram containers. The product is identified by NDC 0395-8077-62 and was packaged in Texarkana, TX.

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 affected lots include A24543, A25724, A25529, A25723, A27120, A27811, A28626, A29171, and A29221, with expiration dates ranging from January 2019 to June 2019.

The product was distributed nationwide. Consumers and healthcare providers should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
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
Manufacturer
Humco Holding Group, Inc
Category
Drug — Active Pharmaceutical Ingredient
Hazard

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 (9)

  • Lots: A24543 Exp. 02/2019
  • A25724 Exp. 01/2019
  • A25529 Exp. 04/2019
  • A25723 Exp. 04/2019
  • A27120 Exp. 05/2019
  • A27811 Exp. 06/2019
  • A28626 Exp. 06/2019
  • A29171 Exp. 06/2019
  • A29221 Exp. 06/2019

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.

See all 3 products in this recall →

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