Maximum Security Toothpaste Recalled for Manufacturing Practice Violations
Maximum Security Anticavity Gel Toothpaste made by KENIL HEALTHCARE is recalled from DE and NC due to CGMP deviations. This voluntary Class II recall was terminated in February 2026.
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: Class II voluntary recall for CGMP deviations with no reported illnesses or injuries, meeting the criterion for moderate severity as a low-risk voluntary precautionary recall.
Plain-English summary
Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, in 1.5 OZ (43 g) tubes has been recalled. The product was manufactured by KENIL HEALTHCARE PRIVATE LIMITED in India and distributed by Bob Barker Co. Inc. in North Carolina. A total of 216,720 tubes with NDC 53247-132-04 were affected.
The recall was initiated on April 24, 2025, due to Current Good Manufacturing Practice (CGMP) deviations. This was a voluntary recall initiated by the firm.
The affected product was distributed in Delaware and North Carolina. The affected lots include B0013 (expires 05/31/2026), B0018 (expires 06/30/2026), B0053 and B0054 (expires 07/31/2026), and B0090 through B0101 (expires 09/30/2026).
Consumers who have or suspect they have this product should discontinue use. The recall was terminated on February 19, 2026.
The recalled product
- 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
- Manufacturer
- KENIL HEALTHCARE PRIVATE LIMITED
- Category
- Drug
- 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 (20)
- 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
Distribution
Distributed in 2 states:
- DE
- NC
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27