Recalls / Class II
Class IID-0434-2025
Product
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
- Affected lot / code info
- Lot B0013, Exp Date: 05/31/2026; Lot B0018, Exp Date: 06/30/2026; Lot B0053, B0054, Exp Date: 07/31/2026; Lot B0090, B0091, B0092, B0093, B0094, B0095, B0096, B0097, B0098, B0099, B0100, B0101, 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
- 216,720 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-0434-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.