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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Fagron and Humco Nandrolone Decanoate Recalled for Being Subpotent

Agency Publication Date: May 11, 2022
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Summary

Fagron, Inc. is recalling 182 containers of Nandrolone Decanoate USP, a medication used for prescription compounding, because the drug is subpotent (weaker than it should be). The recall includes containers in 100 g, 500 g, and 1 kg sizes distributed under both the Fagron and Humco brand names. No incidents or injuries have been reported to date in connection with this recall.

Risk

A subpotent medication may not provide the full therapeutic effect intended by a healthcare provider, which could lead to inadequate treatment for the patient's condition.

What You Should Do

  1. This recall affects Nandrolone Decanoate USP bulk compounding containers sold in 100 g, 500 g, and 1 kg plastic containers under the Fagron and Humco brands.
  2. Check your container label for NDC codes 51552-1564-04, 51552-1564-05, 51552-1564-07, 0395-8212-56, or 0395-8212-43. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Nandrolone Decanoate, USP (100 g)by Fagron
Variants: 100 g plastic container, Rx Only, For Prescription Compounding
Lot Numbers:
18H02-U02-044979 (Exp. 10/31/2022)
18H02-U02-046141 (Exp. 10/31/2022)
18L12-U02-050309 (Exp. Sep 2023)
18L12-U02-000953 (Exp. Sep 2023)
18L12-U02-A009829 (Exp. Sep 2023)
NDC:
51552-1564-04

Fagron, Inc. brand.

Product: Nandrolone Decanoate, USP (500 g)by Fagron
Variants: 500 g plastic container, Rx Only, For Prescription Compounding
Lot Numbers:
18H02-U02-044978 (Exp. 10/31/2022)
18L12-U02-050018 (Exp. 10/31/2022)
18L12-U02-000952 (Exp. Sep 2023)
NDC:
51552-1564-05

Fagron, Inc. brand.

Product: Nandrolone Decanoate, USP (1 kg)by Fagron
Variants: 1 kg plastic container, Rx Only, For Prescription Compounding
Lot Numbers:
18H02-U02-044977 (Exp. 10/31/2022)
18H02-U02-046140 (Exp. 10/31/2022)
18L12-U02-050572 (Exp. 10/31/2022)
18L12-U02-050308 (Exp. Sep 2023)
18L12-U02-000951 (Exp. Sep 2023)
NDC:
51552-1564-07

Fagron, Inc. brand.

Product: Nandrolone Decanoate, USP (500 g)by Humco
Variants: 500 g plastic container, Rx Only, For Prescription Compounding
Lot Numbers:
18L12-U02-050018 (Exp. 10/31/2022)
NDC:
0395-8212-56

Distributed by Humco.

Product: Nandrolone Decanoate, USP (1 kg)by Humco
Variants: 1 kg plastic container, Rx Only, For Prescription Compounding
Lot Numbers:
18L12-U02-050019 (Exp. 10/31/2022)
NDC:
0395-8212-43

Distributed by Humco.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89797
Status: Resolved
Manufacturer: Fagron, Inc
Sold By: compounding pharmacies
Manufactured In: United States
Units Affected: 5 products (58 containers; 53 containers; 68 containers; 2 containers; 1 containers)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.