Medications & Supplements/Prescription Drugs

NorthStarx Febuxostat Tablets Recalled for Potential Microbial Contamination

Agency Publication Date: March 8, 2024

Summary

Sun Pharmaceutical Industries Inc. is recalling 55,008 bottles of NorthStarx Febuxostat (febuxostat) tablets in 40mg and 80mg strengths. This recall was issued because microbial contamination was found in stagnant water within a duct of the manufacturing equipment used to make the medicine. Febuxostat is a prescription drug used to manage high uric acid levels in adults with gout.

Risk

The presence of microbial contamination during the manufacturing process could introduce bacteria into the medication. If consumed, contaminated tablets may cause infections or other serious health issues, particularly in patients with compromised immune systems.

What You Should Do

This recall affects 30-count bottles of NorthStarx Febuxostat Tablets in 40mg and 80mg strengths, which were distributed nationwide.
Identify your medication by checking the bottle for the following details: For 40mg tablets (NDC 16714-059-01), look for lot numbers DNE0865A or DNE0866A with an expiration date of 06/30/2025. For 80mg tablets (NDC 16714-060-01), look for lot number DNE0894A with an expiration date of 07/31/2025.
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 Sun Pharmaceutical Industries Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

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: Febuxostat Tablets (40mg)by NorthStarx

Variants: 40mg, 30 Tablets per bottle, RX Only

Lot Numbers:

DNE0865A (Exp 06/30/2025)

DNE0866A (Exp 06/30/2025)

NDC:

16714-059-01

Product: Febuxostat Tablets (80mg)by NorthStarx

Variants: 80mg, 30 Tablets per bottle, RX Only

Lot Numbers:

DNE0894A (Exp 07/31/2025)

NDC:

16714-060-01

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94142

Status: Active

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Northstar Rx LLC; Pharmacies

Manufactured In: India

Units Affected: 2 products (47,520 bottles; 7,488 bottles)

Distributed To: Nationwide

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 30-count bottles of NorthStarx Febuxostat Tablets in 40mg and 80mg strengths, which were distributed nationwide.

Identify your medication by checking the bottle for the following details: For 40mg tablets (NDC 16714-059-01), look for lot numbers DNE0865A or DNE0866A with an expiration date of 06/30/2025. For 80mg tablets (NDC 16714-060-01), look for lot number DNE0894A with an expiration date of 07/31/2025.

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 Sun Pharmaceutical Industries Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

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: Febuxostat Tablets (40mg)by NorthStarx

Variants: 40mg, 30 Tablets per bottle, RX Only

Lot Numbers:

DNE0865A (Exp 06/30/2025)

DNE0866A (Exp 06/30/2025)

NDC:

16714-059-01

Product: Febuxostat Tablets (80mg)by NorthStarx

Variants: 80mg, 30 Tablets per bottle, RX Only

Lot Numbers:

DNE0894A (Exp 07/31/2025)

NDC:

16714-060-01