Recalls / Class II
Class IID-0430-2025
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
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- Plot 319, Village Acharasan, Ankhol-Vamaj Road, Ta. Kadi, District Mehsana, N/A N/A, India
Distribution
- Quantity
- 383,904 Tubes
- Distribution pattern
- DE and NC
Timeline
- Recall initiated
- 2025-04-24
- FDA classified
- 2025-05-19
- Posted by FDA
- 2025-05-28
- Terminated
- 2026-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0430-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.