The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0865-2022·Announced 2022-05-18

Prescription Compounding Drug Nandrolone Decanoate Recalled for Subpotency

Fagron, Inc. is recalling 2 containers of Nandrolone Decanoate USP used for prescription compounding because the product is subpotent, containing less active ingredient than expected. The recall is nationwide.

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 recall with no reported illnesses or injuries. The hazard is subpotency, a quality defect rather than an acute safety risk. The recall is voluntary and precautionary, meeting the Moderate criterion.

Plain-English summary

Fagron, Inc. is recalling 2 containers of Nandrolone Decanoate, USP (500 g each), a prescription compounding ingredient distributed by Humco under NDC 0395-8212-56. The affected lot is 18L12-U02-050018 with an expiration date of October 31, 2022.

The recall was initiated due to subpotency, meaning the product contains less active ingredient than expected. This quality issue could affect the therapeutic effectiveness of medications prepared using this ingredient.

The product was distributed nationwide throughout the United States to pharmacy compounding facilities and healthcare providers. This is a voluntary recall initiated by the manufacturer on March 4, 2022, and was terminated on July 14, 2024.

The recalled product

Product
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Distributed by: Humco, 7400 Alumax Road, Texarkana, TX 75501. NDC 0395-8212-56
Manufacturer
Fagron, Inc
Category
Drug — Prescription Compounding
Hazard
Affected units
2

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-U02-050018
  • 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 →

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