Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0866-2022·Announced 2022-05-18

FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient

Fagron, Inc initiated a nationwide recall of Nandrolone Decanoate compounding ingredient due to subpotency. The affected lot may contain below-strength concentrations of the active pharmaceutical ingredient.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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: This is an FDA Class III voluntary recall with no reported illnesses or injuries. Subpotency is a quality defect affecting drug efficacy but not creating immediate safety risk. Per the severity rubric, Class III recalls are typically scored 1 or 2, and voluntary quality defects without reported harm score as Moderate.

Plain-English summary

Fagron, Inc initiated a voluntary recall of Nandrolone Decanoate, USP (National Drug Code 0395-8212-43), supplied as 1-kilogram plastic containers for prescription compounding use. The affected lot is #18L12-U02-050019, which expired October 31, 2022. The recall was initiated on March 4, 2022, and reported to the FDA on May 18, 2022.

The product was found to be subpotent, meaning the concentration of the active pharmaceutical ingredient is below the labeled strength. This is a quality defect that could affect the efficacy of compounded preparations made from this material.

The affected lot was distributed nationwide within the United States through the distributor Humco, located at 7400 Alumax Road, Texarkana, Texas 75501. The recall status was terminated on July 14, 2024.

Healthcare providers, compounding facilities, and those who may possess this lot should consult with Fagron, Inc or the FDA for guidance regarding inventory management.

The recalled product

Product: Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-43
Manufacturer: Fagron, Inc
Category: Drug
Hazard: subpotency
Affected units: 1

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 (2)

Lot #: 18L12-U02-050019
Exp. Date 10/31/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Fagron, 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 5 products in this recall →

Same manufacturer · Fagron, Inc

See all →

High
Nystatin Bulk Powder Recalled Due to Incorrect Label Strength
FDA (Drugs) · 2023-12-27
High
Nystatin Bulk Powder Recall for Incorrect Label Assay Value
FDA (Drugs) · 2023-12-27
High
Nystatin Powder Recall Due to Incorrect Assay Strength on Label
FDA (Drugs) · 2023-12-27
High
Nystatin bulk powder recall due to incorrect assay strength label
FDA (Drugs) · 2023-12-27
Moderate
FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient from Fagron
FDA (Drugs) · 2022-05-18

Same hazard · subpotency