The Recall Desk
LowFDA (Drugs)·D-0453-2022·Announced 2022-02-02

CariFree CTx4 GEL 5000 Recalled for Subpotent Fluoride Content

CariFree CTx4 GEL 5000 (Lot 142017) contains less sodium fluoride than stated on the label. The product is being recalled and consumers should contact their healthcare provider with questions.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is subpotency (reduced active ingredient) rather than contamination or overdose risk, making this a labeling/potency documentation issue without evidence of patient harm.

Plain-English summary

Dental Alliance Holdings LLC is recalling CariFree CTx4 GEL 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) tubes (NDC: 61578-205-01, Lot 142017, Expiration Date 06/22). The product contains less sodium fluoride than listed on the product label.

The affected product was distributed nationwide in the United States. Approximately 6,612 individual tubes in 12-pack cases and 15 individual tubes of the 2 oz size were distributed.

Consumers who have this product should contact their healthcare provider if they have questions or concerns. The product is prescription-only (Rx).

The recalled product

Product
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases
Manufacturer
Dental Alliance Holdings LLC
Category
Drug — Topical Fluoride Gel
Hazard
  • subpotency
  • mis-labeling

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 (1)

  • Lot #: 142017 Exp. Date 06/22

Distribution

Distributed nationwide across the United States.

Related recalls

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