Recalls / Class II
Class IID-0432-2025
Product
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03
- Affected lot / code info
- Lot B0008, B0009, B0017, Exp Date: 05/31/2026; Lot B0042, B0043, B0044, Exp Date: 06/30/2026; Lot B0049, B0050, B0051, B0054, B0058, B0059, Exp Date: 07/31/2026; Lot B0061, B0062, B0063, B0064, B0065, B0068, B0069, Exp Date: 08/31/2026
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
- 615, 600 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-0432-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.