Pritam International Recalls Brush Buddies Fluoride Toothpaste for CGMP Deviations
Pritam International is voluntarily recalling 411,600 tubes of Brush Buddies Hot Wheels Anticavity Fluoride Toothpaste due to Current Good Manufacturing Practice (CGMP) deviations.
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 411,600 tubes of Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, Strawberry Flavor, 4.0 oz (113g). The recall was initiated on September 10, 2026, and is currently ongoing. The product is distributed by Ashtel Studios Inc. in Ontario, California, and was distributed nationwide in the United States.
The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. The source text does not specify the exact nature of the manufacturing deviations or report any illnesses, injuries, or deaths associated with the product.
The affected product is identified by NDC 84140-002-40, Item # 88047, and UPC 8 10147 88047 8. Specific lot numbers and expiration dates are listed in the recall details. Consumers should check their toothpaste for these specific lot numbers and expiration dates to determine if their product is affected.
The recalled product
- Product
- Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-002-40, Item # 88047, UPC 8 10147 88047 8
- Manufacturer
- PRITAM INTERNATIONAL PRIVATE LIMITED
- Category
- Drug — Toothpaste
- Hazard
- Affected units
- 411,600
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 (12)
- Lot# LWP250031810502B
- Exp Date: 02/26/2027
- Lot# LWP250032571702B
- Exp Date: 03/05/2027
- Lot# LWP250035710304B
- Exp Date: 04/17/2027
- Lot# LWP260052231401
- Exp Date: 02/17/2028
- Lot# LWP0054880903A
- Exp Date: 04/30/2028
- Lot# LWP250035370104
- Exp Date: 12/4/2028.
Distribution
Distributed nationwide across the United States.
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