Pritam International Recalls ARU Toothpaste Due to Manufacturing Deviations
Pritam International is voluntarily recalling 15,264 tubes of ARU Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide in the US.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II due to CGMP deviations, and the source does not report any illnesses, injuries, or deaths.
Plain-English summary
Pritam International Private Limited is voluntarily recalling 15,264 tubes of ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint. The recall was initiated by the firm on September 10, 2026, due to Current Good Manufacturing Practice (CGMP) deviations. The product is distributed by Ashtel Studios Inc. in Ontario, California, and was available nationwide in the United States.
The affected product is identified by NDC 84140-785-35, Item # 88785, and UPC 8 10147 88785. Two specific lots are involved: Lot # LWP250047850611C with an expiration date of 12/22/2027, and Lot # LWP260052612201C with an expiration date of 3/31/2028. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.
Consumers who have purchased this product should check their lot numbers and expiration dates against the information provided. If they possess the affected product, they should stop using it and contact the distributor or manufacturer for further instructions or a refund. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- 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
- Manufacturer
- PRITAM INTERNATIONAL PRIVATE LIMITED
- Category
- Drug — Dental
- Hazard
- Affected units
- 15,264
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # LWP250047850611C
- Exp Date: 12/22/2027
- Lot # LWP260052612201C
- Exp Date: 3/31/2028.
Distribution
Distributed nationwide across the United States.
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