Medications & Supplements/Prescription Drugs

Fagron Nystatin Compounding Powder Recalled for Labeling Strength Error

Agency Publication Date: December 20, 2023

Summary

Fagron, Inc. is recalling 120 containers of Nystatin bulk powder (nystatin) used for prescription compounding because the label strength (assay value) is incorrect. The recall affects four different dosage strengths of the bulk powder distributed to pharmacies and distributors across the United States and Canada. This labeling error means medications compounded with this powder could contain the wrong amount of the active ingredient.

Risk

The incorrect strength on the label can lead to pharmacy compounding errors, resulting in medications that are either too strong or too weak. This may cause patients to receive an improper dose, which could lead to treatment failure or potential side effects.

What You Should Do

This recall affects bulk powder containers of Nystatin (150 MU, 500 MU, 2 BU, and 5 BU) sold under the Fagron, Inc. label for use in prescription compounding.
Identify affected products by checking for NDC numbers 51552-0041-1, 51552-0041-3, 51552-0041-4, or 51552-0041-5 with an expiration date of 04/30/2025.
Check your container for the following lot numbers: 230308-U46196, 230308-U46225, 221031-U42110, 230308-U46224, 221031-U42105, or 221031-U42104.
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 Fagron, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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: Nystatin 5BU bulk powder container

Variants: 5BU, Activity (as is): 6482 Units/mg

UPC Codes:

351552004153

Lot Numbers:

230308-U46196 (Exp 04/30/2025)

NDC:

51552-0041-5

Rx Only, For Prescription Compounding

Product: Nystatin 500 MU bulk powder container

Variants: 500 MU, Activity (as is): 6482 Units/mg

UPC Codes:

351552004139

Lot Numbers:

230308-U46225 (Exp 04/30/2025)

221031-U42110 (Exp 04/30/2025)

NDC:

51552-0041-3

Rx Only, For Prescription Compounding

Product: Nystatin 2 BU bulk powder container

Variants: 2 BU, Activity (as is): 6482 Units/mg

UPC Codes:

351552004146

Lot Numbers:

230308-U46224 (Exp 04/30/2025)

221031-U42105 (Exp 04/30/2025)

NDC:

51552-0041-4

Rx Only, For Prescription Compounding

Product: Nystatin 150 MU bulk powder container

Variants: 150 MU, Activity (as is): 6482 Units/mg

UPC Codes:

351552004115

Lot Numbers:

221031-U42104 (Exp 04/30/2025)

NDC:

51552-0041-1

Rx Only, For Prescription Compounding

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93594

Status: Active

Manufacturer: Fagron, Inc

Sold By: distributors; repacker/relabelers; pharmacies

Manufactured In: United States

Units Affected: 4 products (13 containers; 46 containers; 9 containers; 52 containers)

Distributed To: Nationwide

Agency Last Updated: December 21, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 · 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.

Summary

What You Should Do

This recall affects bulk powder containers of Nystatin (150 MU, 500 MU, 2 BU, and 5 BU) sold under the Fagron, Inc. label for use in prescription compounding.

Identify affected products by checking for NDC numbers 51552-0041-1, 51552-0041-3, 51552-0041-4, or 51552-0041-5 with an expiration date of 04/30/2025.

Check your container for the following lot numbers: 230308-U46196, 230308-U46225, 221031-U42110, 230308-U46224, 221031-U42105, or 221031-U42104.

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 Fagron, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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: Nystatin 5BU bulk powder container

Variants: 5BU, Activity (as is): 6482 Units/mg

UPC Codes:

351552004153

Lot Numbers:

230308-U46196 (Exp 04/30/2025)

NDC:

51552-0041-5

Rx Only, For Prescription Compounding

Product: Nystatin 500 MU bulk powder container

Variants: 500 MU, Activity (as is): 6482 Units/mg

UPC Codes:

351552004139

Lot Numbers:

230308-U46225 (Exp 04/30/2025)

221031-U42110 (Exp 04/30/2025)

NDC:

51552-0041-3

Rx Only, For Prescription Compounding

Product: Nystatin 2 BU bulk powder container

Variants: 2 BU, Activity (as is): 6482 Units/mg

UPC Codes:

351552004146

Lot Numbers:

230308-U46224 (Exp 04/30/2025)

221031-U42105 (Exp 04/30/2025)

NDC:

51552-0041-4

Rx Only, For Prescription Compounding

Product: Nystatin 150 MU bulk powder container

Variants: 150 MU, Activity (as is): 6482 Units/mg

UPC Codes:

351552004115

Lot Numbers:

221031-U42104 (Exp 04/30/2025)

NDC:

51552-0041-1

Rx Only, For Prescription Compounding

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93594

Status: Active

Manufacturer: Fagron, Inc

Sold By: distributors; repacker/relabelers; pharmacies

Manufactured In: United States

Units Affected: 4 products (13 containers; 46 containers; 9 containers; 52 containers)

Distributed To: Nationwide

Agency Last Updated: December 21, 2023