FEBUXOSTAT Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pha Recall 2024
FEBUXOSTATIssued January 18, 2024
FEBUXOSTAT Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 — recalled per FDA on 1/18/2024. Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment..
What to do right now
- 1
Stop using it
Take it out of rotation. Don't consume, wear, or operate.
- 2
Verify the match
Compare lot numbers, UPCs, and dates against your product.
- 3
Return or dispose
Follow the manufacturer's instructions to refund or safely dispose.
Verified source
U.S. Food and Drug Administration
Summary of the official FDA notice issued January 18, 2024. Last synced Apr 27, 2026. View on fda.gov
What's recalled
Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Affected products & lot numbers3 lots called out
Affected Lot Numbers
Check your product label — do not use if your lot number appears below.
| Lot Number |
|---|
| Lot #s: DNE0866B Exp. 06/30/2025 |
| DNE1045A |
| DNE1046B Exp. 08/31/2025 |
Where was it sold1 state
Nationwide in the USA
View all questions for this recall →
More recalls like this6 related — by brand, contaminant, and category
Other FEBUXOSTAT recalls
Recent Medications recalls
- F.H. INVESTMENTS, Inc. (dba Asteria Health) ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingh Recall 20262026
- F.H. INVESTMENTS, Inc. (dba Asteria Health) ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham Recall 20262026
- F.H. INVESTMENTS, Inc. (dba Asteria Health) ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, Recall 20262026
Frequently asked questions
Is the FEBUXOSTAT recall still active?
Yes, this recall is currently active as of January 18, 2024. Do not use or consume the affected product.
What lot numbers are affected?
Affected lot numbers: Lot #s: DNE0866B Exp. 06/30/2025, DNE1045A, DNE1046B Exp. 08/31/2025. Check the label on your product.
What should I do if I have the recalled FEBUXOSTAT?
Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.