CLASS II Drug recall · Reported 31 Jan 2024 · FDA Enforcement Report
Febuxostat Tablets 80 mg recalled by Sun Pharmaceutical Industries
SUN Pharmaceutical Industries is recalling Febuxostat Tablets 80 mg, distributed nationwide in the US. The recall was initiated on 18 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0265-2024
- FDA event ID
- 93820
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Febuxostat
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 18 Jan 2024
- FDA classified
- 25 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 18 Jan 2024 | Recall initiated by company | |
| 25 Jan 2024 | Classified by FDA | +7 days |
| 31 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Febuxostat Tablets 80 mg, 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 47335-722-83.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Which lots are affected?
Lot #s: DNE0867A Exp. 06/30/2025, DNE0894B Exp. 07/31/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 93820This product is part of a recall event; the main page for the event is Lurasidone Hydrochloride Tablets 60mg recalled.
More recalls from SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Febuxostat recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Febuxostat Tablets 40mg recalled by Sun Pharmaceutical IndustriesFebuxostat | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Febuxostat Tablets 80mg recalled by Sun Pharmaceutical IndustriesFebuxostat | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Febuxostat Tablets, 40 mg (3 recalled by Amerisource Health ServicesFebuxostat | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Febuxostat Tablets 40mg recalled by Sun Pharmaceutical IndustriesFebuxostat | SUN Pharmaceutical Industries | Sterility | Nationwide |
| Drug | CLASS II | Febuxostat Tablet, 40 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |