Sunstar GUM Recalls 3g Toothpaste Tubes Due to cGMP Deviation
Sunstar Guangzhou Ltd. recalls specific lots of Sunstar GUM 3g toothpaste tubes due to current good manufacturing practice deviations.
Recall notice
cGMP Deviation
Contact the company
What happened, in plain English
Sunstar Guangzhou Ltd. is recalling approximately 260,000 tubes of Sunstar GUM Toothpaste (3 g) because they were manufactured in violation of current Good Manufacturing Practices (cGMP). The affected products were made in Japan and packed in China. The recall was issued on February 28, 2020. Read more at govinfonow.com/recall/37354-sunstar-gum-recalls-3g-toothpaste-tubes-due-to-cgmp-deviation.
Source Summary by GovInfoNow · govinfonow.com/recall/37354-sunstar-gum-recalls-3g-toothpaste-tubes-due-to-cgmp-deviation · Updated October 11, 2026 · FDA enforcement record: FDA #D-0997-2020
Cite this page
“Sunstar GUM Recalls 3g Toothpaste Tubes Due to cGMP Deviation.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37354-sunstar-gum-recalls-3g-toothpaste-tubes-due-to-cgmp-deviation. 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 recall is due to a cGMP deviation, which means the manufacturing process did not meet federal quality standards. The record does not specify what specific quality issues occurred or if they pose a direct health risk to users.
Who’s affected
Consumers in Florida who purchased the specific lots of Sunstar GUM Toothpaste 3 g tubes between the production dates and before the expiration dates listed below are likely affected.
How to tell if you have this one
Check your toothpaste tube for the brand name 'Sunstar GUM' and the size '3 g'. Look for one of the following Lot Numbers and Expiration Dates printed on the packaging: Lot #20180621 (Exp. 2020-06-21), Lot #20180827 (Exp. 2020-08-27), or Lot #190115 (Exp. 2021-01-15). The National Drug Code (NDC) is 53050-0002-01.
- Brand
Sunstar GUM- Category
Drug
Where it went and when
Where it was distributed
Distributed in Florida.
FDA distribution: “Florida only” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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 qwen3.6:35b-a3b on October 11, 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.