Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01

Recall Insight

This FDA Drug action (record #D-0997-2020) was formally reported on March 18, 2020, with the manufacturer initiating the action on February 28, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Sunstar Guangzhou Ltd. is listed as the recalling firm, operating out of Guangzhou. Federal records indicate 260,000 tubes units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: cGMP Deviation Distribution data in the federal record shows the product reached: Florida only. 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 and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 4 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 6 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.