The Recall Desk
ModerateFDA (Drugs)·D-0430-2025·Announced 2025-05-28

Cinnafresh Anticavity Gel Toothpaste Recalled Due to CGMP Deviations

Cinnafresh anticavity gel toothpaste (sodium fluoride 0.22%, Bold Cinnamon Flavor) is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The manufacturer, KENIL HEALTHCARE PRIVATE LIMITED, initiated this voluntary recall.

What this means for you

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: This is an FDA Class II recall with no reported illnesses or injuries. CGMP deviations represent a manufacturing process issue without confirmed direct harm to consumers, making it a precautionary voluntary recall that meets the Moderate severity threshold.

Plain-English summary

Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, in 0.85 OZ (24 grams) tubes is being recalled. The product is distributed by Bob Barker Co. Inc. (Fuquay-Varina, NC) and was made in India. The recall was initiated on April 24, 2025, and involves approximately 383,904 tubes.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. KENIL HEALTHCARE PRIVATE LIMITED, the manufacturer, voluntarily initiated this recall.

The affected product was distributed in Delaware and North Carolina. The affected lot codes and expiration dates are: Lot B0011 and B0012 (Exp. 05/31/2026); Lot B0070 and B0074 (Exp. 08/31/2026); and Lot B0075, B0077, B0078, B0079, B0080, B0081, B0082, B0083, B0084, and B0085 (Exp. 09/30/2026). The NDC number is 53247-133-01.

Consumers who have this product should stop using it.

The recalled product

Product
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-133-01
Manufacturer
KENIL HEALTHCARE PRIVATE LIMITED
Category
Drug — Toothpaste / Oral Care
Hazard
Affected units
383,904

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 (17)

  • Lot B0011
  • B0012
  • Exp Date: 05/31/2026
  • Lot B0070
  • B0074
  • Exp Date: 08/31/2026
  • Lot B0075
  • B0077
  • B0078
  • B0079
  • B0080
  • B0081
  • B0082
  • B0083
  • B0084
  • B0085
  • Exp Date: 09/30/2026

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 20 recalled by KENIL HEALTHCARE PRIVATE LIMITED under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

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