Pritam International Recalls evo Fluoride Toothpaste for CGMP Deviations
Pritam International is voluntarily recalling 405,336 tubes of evo toothpaste nationwide 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 405,336 tubes of evo, Advanced Whitening, Anticavity Fluoride Toothpaste (sodium fluoride 0.24%) Peppermint, Net Wt. 3.5 oz (99g). The product is distributed by Ashtel Studios Inc. and is identified by NDC 84140-886-19, Item# 88619, and UPC 8 10147 88619 7.
The recall was initiated on September 10, 2026, due to Current Good Manufacturing Practice (CGMP) deviations. The affected product was distributed nationwide in the United States. The recall covers eight specific lots with expiration dates ranging from August 3, 2027, to March 29, 2028.
The FDA has classified this recall as Class II. The source text does not report any illnesses, injuries, or deaths associated with the product. Consumers should stop using the affected toothpaste and contact the distributor or manufacturer for further instructions.
The recalled product
- Product
- evo, Advanced Whitening, Anticavity Fluoride Toothpaste, (sodium fluoride 0.24%) Peppermint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-886-19, Item# 88619, UPC 8 10147 88619 7
- Manufacturer
- PRITAM INTERNATIONAL PRIVATE LIMITED
- Category
- Drug — Toothpaste
- Hazard
- Affected units
- 405,336
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 (16)
- Lot# LWP250038750606
- Exp Date: 08/03/2027
- Lot# LWP250045152409A
- Exp Date: 10/06/2027
- Lot# LWP250046862110A
- Exp Date: 11/11/2027
- Lot# LWP250047640511B
- Exp Date: 12/17/2027
- Lot# LWP250051172312A
- Exp Date: 01/25/2028
- Lot# LWP250051182312B
- Exp Date: 01/28/2028
- Lot# LWP260052241401B
- Exp Date: 03/18/2028
- Lot# LWP0054880903F
- Exp Date: 03/29/2028.
Distribution
Distributed nationwide across the United States.
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