FDA Drugs recall ·
ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint… recall
- Recall number
- D-0068-2027
- Date
- (initiated September 10, 2026)
- Company / brand
- Pritam International Private Limited
Khasra No. 138, Raipur Industrial Area, Haridwar, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15,264 tubes
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-786-35, Item # 88786 UPC 8 10147 88786 6
Why was it recalled?
CGMP Deviations.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # LWP250047850611D, Exp Date: 12/23/2027; Lot # LWP260052612201D, Exp Date: 04/30/2028.
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0068-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.