Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall:
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.

Product Codes/Lot Numbers:

Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0368-2024

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