CLASS II Drug recall · Reported 18 Mar 2020 · FDA Enforcement Report
Sunstar GUM Toothpaste tubes, Toothpaste recalled by Sunstar Guangzhou
Sunstar Guangzhou is recalling Sunstar GUM Toothpaste tubes, Toothpaste, distributed in Florida. The recall was initiated on 28 Feb 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0997-2020
- FDA event ID
- 85127
- Recalling firm
- Sunstar Guangzhou, Guangzhou
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2020
- FDA classified
- 9 Mar 2020
- Reported
- 18 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Sunscreen & Personal Care
Timeline
| 28 Feb 2020 | Recall initiated by company | |
| 9 Mar 2020 | Classified by FDA | +10 days |
| 18 Mar 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviation
Product as listed by the FDA
Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
Where it was distributed
Florida only
Questions about this recall
Is Sunstar GUM Toothpaste tubes, Toothpaste recalled?
Yes. Sunstar Guangzhou recalled Sunstar GUM Toothpaste tubes, Toothpaste on 28 Feb 2020. The recall is Class II and its status is Terminated. Recall number D-0997-2020.
Why was it recalled?
cGMP Deviation
Which lots are affected?
Lot #: 20180621 Exp. 2020-06-21, 20180827 Exp. 2020-08-27, 20190115 Exp. 2021-01-15
Where was it sold?
Florida only
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.