Sunstar Guangzhou Ltd. recalls Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
Sunstar recalls gum toothpaste tubes made in Japan, packed in China with a cGMP deviation. Check NDC 53050-0002-01 and expiration dates for affected products.
Lower-risk recall
cGMP Deviation
Contact the company & request your remedy
What happened, in plain English
Sunstar is recalling gum toothpaste tubes that were made in Japan and packed in China due to a cGMP deviation. This means the toothpaste may not meet quality standards, though no injuries have been reported. Read more at govinfonow.com/recall/37354-sunstar-gum-toothpaste-recall-c-g-m-p-deviation-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37354-sunstar-gum-toothpaste-recall-c-g-m-p-deviation-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0997-2020
Cite this page
“Sunstar Gum Toothpaste Recall: C G M P Deviation Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37354-sunstar-gum-toothpaste-recall-c-g-m-p-deviation-risk. Based on FDA recall #D-0997-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0997-2020%22&limit=1).
Why it’s dangerous
The toothpaste was produced under a cGMP (current Good Manufacturing Practice) deviation, which means it may not meet quality standards. This could lead to issues with the product's safety or effectiveness, but no injuries have been reported.
Who’s affected
People who own or use Sunstar gum toothpaste tubes with NDC 53050-0002-01 and expiration dates listed in the recall. Those with the specific lot numbers are most at risk.
How to tell if you have this one
Check for Sunstar gum toothpaste tubes with NDC 53050-0002-01. Look for lot numbers: 20180621 (expires 2020-06-21), 20180827 (expires 2020-08-27), or 20190115 (expires 2021-01-15).
- Brand
Sunstar- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 53050-0002-01 and the specific lot numbers listed in the recall.
Questions people ask
Is this toothpaste dangerous?
The recall is due to a cGMP deviation, which means the toothpaste may not meet quality standards. No injuries have been reported.
How do I know if I have the recalled product?
Check for Sunstar gum toothpaste tubes with NDC 53050-0002-01 and lot numbers: 20180621 (expires 2020-06-21), 20180827 (expires 2020-08-27), or 20190115 (expires 2021-01-15).
What should I do with the recalled toothpaste?
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
Contact Sunstar
We’ve drafted a message you can send Sunstar to request your refund or repair — edit it as you like.
Subject: Recall D-0997-2020 — Sunstar Sunstar Hello, I own a Sunstar that is covered by recall D-0997-2020 from Sunstar. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0997-2020 (February 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0997-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.