Sunstar GUM Toothpaste (Sunstar) – Manufacturing Deviation (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
Brand
Sunstar Guangzhou Ltd.
Lot Codes / Batch Numbers
Lot #: 20180621 Exp. 2020-06-21, 20180827 Exp. 2020-08-27, 20190115 Exp. 2021-01-15
Products Sold
Lot #: 20180621 Exp. 2020-06-21, 20180827 Exp. 2020-08-27, 20190115 Exp. 2021-01-15
Sunstar Guangzhou Ltd. is recalling Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01 due to cGMP Deviation. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP Deviation
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL
Page updated: Jan 7, 2026