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.
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 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
- subpotency
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.
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