Cinnafresh Anticavity Gel Toothpaste Recalled for Manufacturing Deviations
Cinnafresh anticavity gel toothpaste made in India is being recalled due to CGMP manufacturing deviations. The recall affects 383,904 tubes distributed in Delaware and North Carolina.
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 a voluntary, firm-initiated FDA Class II recall with no reported illnesses, injuries, or specific hazard identified beyond manufacturing process deviations. Per the rubric, voluntary precautionary recalls without reported adverse effects are classified as Moderate.
Plain-English summary
Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor (0.85 oz tubes, NDC 53247-133-01) manufactured in India by KENIL HEALTHCARE PRIVATE LIMITED and distributed by Bob Barker Co. Inc. of Fuquay-Varina, NC, is being recalled. The recall affects approximately 383,904 tubes.
The recall was initiated on April 24, 2025, due to Good Manufacturing Practice (CGMP) deviations identified during the manufacturing process. The FDA classified this as a Class II recall. Affected lots include B0011, B0012 (expiring 05/31/2026), B0070, B0074 (expiring 08/31/2026), and B0075 through B0085 (expiring 09/30/2026). The product was distributed in Delaware and North Carolina.
This is a voluntary, firm-initiated recall that was terminated on February 19, 2026. Consumers possessing affected product should discontinue use. Retailers and healthcare providers should follow FDA guidance regarding the return or destruction of affected product.
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 — Oral Care / Toothpaste
- Hazard
- cgmp-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 (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:
- DE
- NC
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