Sodium Fluoride Activator Concentrate Recalled for Manufacturing Practice Violations
Ecometics, Inc. is recalling 32,583 bottles of Sodium Fluoride 0.96% Activator Concentrate nationwide due to manufacturing practice deviations. The product was not manufactured under current good manufacturing practices (CGMP).
What this means for you
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 recall due to manufacturing practice deviations. The product was not manufactured under Current Good Manufacturing Practices (CGMP), which constitutes a potential risk of harm to consumers by affecting product quality, purity, and safety assurance. No illnesses or injuries have been reported. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' warranting a High (3) classification.
Plain-English summary
Ecometics, Inc. is recalling 32,583 bottles of Sodium Fluoride 0.96% Activator Concentrate (Net 1 FL. OZ., Lot 1E175B, expiration 6/24) due to Current Good Manufacturing Practice (CGMP) deviations. The product, manufactured for All USA Direct, LLC in Broadview, Illinois, was not produced under CGMP requirements, which establish the standards for quality, purity, and safety in pharmaceutical manufacturing.
The affected product was distributed nationwide in the United States. The recalled lot number is 1E175B with an expiration date of 6/24.
Consumers who have purchased this product should stop using it and consult their healthcare provider or dentist regarding any previous use. Consumers should dispose of the product safely or return it to the point of purchase.
The recalled product
- Product
- activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.
- Manufacturer
- Ecometics, Inc.
- Category
- Drug — Dental / Fluoride
- Hazard
- manufacturing-deviation
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 (2)
- Lot: 1E175B
- exp 6/24
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27