The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0862-2022·Announced 2022-05-18

Fagron recalls Nandrolone Decanoate USP for subpotency in multiple lots

Fagron, Inc. is recalling 58 containers of Nandrolone Decanoate USP for prescription compounding due to subpotency. The affected lots were distributed 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 a Class III voluntary pharmaceutical recall with no reported illnesses or adverse events. The hazard is subpotency, which affects therapeutic efficacy rather than acute safety.

Plain-English summary

Fagron, Inc. is recalling 58 containers of Nandrolone Decanoate, USP, 100 g per plastic container, a prescription compounding pharmaceutical. The recall was initiated because the product was found to be subpotent—containing less active pharmaceutical ingredient than specified.

The affected product was distributed nationwide within the United States. The recalled lots are: 18H02-U02-044979 and 18H02-U02-046141 (expiring 10/31/2022), and 18L12-U02-050309, 18L12-U02-000953, and 18L12-U02-A009829 (expiring September 2023).

Healthcare providers and patients who have received this product should not use it and should contact their pharmacy or the recalling firm for guidance on replacement product.

The recalled product

Product
Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-04
Manufacturer
Fagron, Inc
Category
Drug — Prescription Compounding
Hazard
Affected units
58

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-U02-044979
  • 18H02-U02-046141
  • Exp. Date 10/31/2022
  • 18L12-U02-050309
  • 18L12-U02-000953
  • 18L12-U02-A009829
  • 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 →

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