FDA-Drug2026-10-19Class IIPROCESSING DEFECT

evo Sensitive Anticavity Fluoride Toothpaste recalled for CGMP manufacturing deviations

OTHERNationwide distributionDrugsCosmetics

What this means

evo Sensitive Anticavity Fluoride Toothpaste (Sweet Mint, 3.5 oz) distributed by Ashtel Studios Inc. is being recalled due to manufacturing process deviations that do not meet federal standards. Seven specific lot numbers with expiration dates from August 2027 through April 2028 are affected nationwide.

  • Check if you have one of the affected lots (see lot numbers and expiration dates on FDA recall notice)
  • Stop using the product if you have an affected lot
  • Contact the distributor or retailer for instructions on return or replacement
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The agency's original wording
Hazard

CGMP Deviations.

Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
389,880 tubes
Manufactured in
Khasra No. 138, Raipur Industrial Area, Bhagwanpur, Haridwar, India
Products
evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0060-2027

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