Why it was recalled
CGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
DE and NC
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0432-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 24, 2025
- FDA report date
- May 28, 2025
- Quantity
- 615, 600 Tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- KENIL HEALTHCARE PRIVATE LIMITED
Original FDA data
Every field from FDA enforcement report D-0432-2025, exactly as published.
Show all FDA fields
- City
- Ta. Kadi, District Mehsana
- Status
- Terminated
- Country
- India
- Event ID
- 96797
- Address
- Plot 319
- Address (line 2)
- Village Acharasan, Ankhol-Vamaj Road
- Code information
- 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
- Report date
- May 28, 2025
- Product type
- Drugs
- Recall number
- D-0432-2025
- Classification
- Class II
- Recalling firm
- KENIL HEALTHCARE PRIVATE LIMITED
- Product quantity
- 615, 600 Tubes
- Termination date
- Feb 19, 2026
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- DE and NC
- Recall initiation date
- Apr 24, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 19, 2025