The Recall Desk
ModerateFDA (Drugs)·D-0863-2022·Announced 2022-05-18

FDA recalls Nandrolone Decanoate compounding ingredient for subpotency nationwide

Fagron, Inc. recalls 53 containers of Nandrolone Decanoate compounding ingredient due to subpotency. The product was distributed 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: FDA Class III recall for a pharmaceutical quality defect (subpotency) with no reported illnesses or injuries. Class III recalls are typically assigned scores of 1 or 2; subpotency is a potency and efficacy issue rather than a direct safety hazard.

Plain-English summary

Fagron, Inc. is recalling Nandrolone Decanoate, USP, a prescription compounding ingredient. The recall involves 53 containers of 500 grams each, identified by NDC 51552-1564-05.

The recall was initiated due to subpotency—the product contains less active pharmaceutical ingredient than labeled. Fagron voluntarily initiated the recall on March 4, 2022. The affected product includes lot numbers 18H02-U02-044978, 18L12-U02-050018, and 18L12-U02-000952.

The product was distributed nationwide within the United States. The recall was classified as Class III by the FDA and was terminated on July 14, 2024.

The recalled product

Product
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
Manufacturer
Fagron, Inc
Category
Drug — Compounding Ingredient
Hazard
  • subpotent

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 (4)

  • Lot #: 18H02-U02-044978
  • 18L12-U02-050018
  • Exp. Date 10/31/2022 18L12-U02-000952
  • Exp. Date Sep 2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category