Toothpaste Label Mix-Up: Wrong Tube Labels in Strawberry Cartons
Hello wild strawberry fluoride toothpaste cartons contain tubes incorrectly labeled as hello fresh watermelon fluoride free toothpaste. 182,046 units affected nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II labeling error affecting 182,046 units with no reported illnesses or injuries. This mislabeling creates a risk of harm, as consumers may unknowingly use a product formulation different from what they expected. The difference between a fluoride-containing and fluoride-free formulation represents a material difference in product composition.
Plain-English summary
Colgate Palmolive Company is recalling hello wild strawberry fluoride toothpaste (182,046 tubes) distributed by Hello Products LLC, Montclair, NJ. The product was distributed nationwide. Affected lot numbers are 004287, 2267USA94A, 2271USA94A (expiring 08/2024), 3053USA94A (expiring 01/2025), and 3156USA94A and 3157USA94A (expiring 05/2025).
The recall is due to a labeling error: cartons are labeled as hello wild strawberry fluoride toothpaste, but the tubes inside are labeled as hello fresh watermelon fluoride free toothpaste. This mismatch means consumers may use a product with different ingredients and fluoride content than they intended based on the carton label.
The recalled product
- Product
- hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v fluoride ion), NET WT 4.2 OZ (119 g), Distributed by Hello Products LLC, Montclair, NJ 07042, UPC 8 19156 02026 4 (carton), 12-count case GTIN: 20819156020268; strawberry tubes also sold in Strawberry…
- Manufacturer
- Colgate Palmolive Company
- Category
- Drug — Oral Care
- Hazard
- Affected units
- 182,046
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 (9)
- Lot #: 004287
- 2267USA94A
- 2271USA94A
- EXP 08/2024
- 3053USA94A
- Exp 01/2025
- 3156USA94A
- 3157USA94A
- EXP 05/2025
Distribution
Distributed nationwide across the United States.
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