The Recall Desk
ModerateFDA (Drugs)·D-0864-2022·Announced 2022-05-18

FDA Recalls Subpotent Nandrolone Decanoate Compounding Ingredient from Fagron

Fagron Inc. initiated a voluntary recall of 68 containers of Nandrolone Decanoate USP in March 2022 after the product was found subpotent, containing less active ingredient than labeled. The recall affects compounding pharmacies nationwide.

What this means for you

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. It involves subpotency in a compounding ingredient, consistent with the 'voluntary precautionary recalls' criterion for Moderate severity.

Plain-English summary

Fagron, Inc. is recalling 68 containers of Nandrolone Decanoate, USP, a steroid ingredient used by pharmacies to prepare prescription medications. Each container holds 1 kilogram (NDC 51552-1564-07).

The company initiated this voluntary recall in March 2022 after determining that batches of the product contained less active ingredient than labeled. Affected lot numbers are 18H02-U02-044977, 18H02-U02-046140, 18L12-U02-050572 (expiring 10/31/2022) and 18L12-U02-050308, 18L12-U02-000951 (expiring September 2023). The product was distributed nationwide.

Compounding pharmacies that received this ingredient may have used it to prepare patient medications without knowing the drug was subpotent. Patients who received such medications should consult their pharmacy or healthcare provider if they have concerns about treatment efficacy. The FDA classified this as a Class III recall, which was terminated in July 2024.

The recalled product

Product
Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-07
Manufacturer
Fagron, Inc
Category
Drug — Compounding Ingredient
Hazard
Affected units
68

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 (7)

  • Lot #: 18H02-U02-044977
  • 18H02-U02-046140
  • 18L12-U02-050572
  • Exp. Date 10/31/2022
  • 18L12-U02-050308
  • 18L12-U02-000951
  • Exp. Date Sep 2023

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 →

Related recalls

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Same hazard · subpotency

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