CLASS II ONGOING Drug recall · Reported 28 Oct 2026 · FDA Enforcement Report
ARU, Toothpaste, Cavity Protection, 9 Ingredients recalled
Pritam International Private is recalling ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%), distributed nationwide in the US. The recall was initiated on 10 Sep 2026 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-0069-2027
- FDA event ID
- 99849
- Recalling firm
- Pritam International Private, Haridwar
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Sep 2026
- FDA classified
- 19 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Sunscreen & Personal Care
Timeline
| 10 Sep 2026 | Recall initiated by company | |
| 19 Oct 2026 | Classified by FDA | +39 days |
| 28 Oct 2026 | 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 Deviations.
Product as listed by the FDA
ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-785-35, Item # 88785, UPC 8 10147 88785
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations.
Which lots are affected?
Lot # LWP250047850611C, Exp Date: 12/22/2027; Lot # LWP260052612201C, Exp Date: 3/31/2028.
Where was it sold?
US Nationwide.
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 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 99849This product is part of a recall event; the main page for the event is Brush Buddies, Mint Chocolate Chip Ice Cream Flavored recalled.
More recalls from Pritam International Private
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Brush Buddies, Cookies 'n Cream Ice Cream Flavored recalled | Pritam International Private | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste recalled | Pritam International Private | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Brush Buddies, Crayola, Silly Scents recalled | Pritam International Private | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Brush Buddies, Barbie, Anticavity Fluoride Toothpaste recalled | Pritam International Private | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Brush Buddies, Vanilla Ice Cream Flavored Toothpaste recalled | Pritam International Private | Manufacturing (CGMP) Deviations | Nationwide |