Febuxostat Tablets 40mg recall
FDA recall D-0368-2024 · initiated Mar 4, 2024
SUN PHARMACEUTICAL INDUSTRIES INC recalled Febuxostat Tablets 40mg in Mar 2024 — an FDA Class II recall (D-0368-2024) because CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 47,520 bottles
Details
- Product
- 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.
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Initiated
- Mar 4, 2024
- FDA report date
- Mar 20, 2024
Frequently asked
- Was Febuxostat Tablets 40mg recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Febuxostat Tablets 40mg in Mar 2024 — an FDA Class II recall (D-0368-2024) because CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Febuxostat Tablets 40mg recalled?
- Per the FDA enforcement record, the reason for recall D-0368-2024 was: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- Is a recalled Febuxostat Tablets 40mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Febuxostat Tablets 40mg are affected?
- Distributed: Nationwide. The recall covers these lots — Lot #s: DNE0865A, DNE0866A, Exp 06/30/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0368-2024.