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.

Recall Insight

This FDA Drug action (record #D-0368-2024) was formally reported on March 20, 2024, with the manufacturer initiating the action on March 4, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. SUN PHARMACEUTICAL INDUSTRIES INC is listed as the recalling firm, operating out of Princeton, NJ. Federal records indicate 47,520 bottles units are affected.

The documented reason for this recall is: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.