Data Foundry

Drug recalls 2025

Maximum Security Anticavity Gel Toothpaste — Class II drug recall D-0431-2025

Terminated recall by KENIL HEALTHCARE PRIVATE LIMITED, reported 2025-05-28, distributed in DE, NC. CGMP Deviations

Recall numberD-0431-2025
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmKENIL HEALTHCARE PRIVATE LIMITED, Ta. Kadi, District Mehsana, N/A, India
Recall initiated2025-04-24
Classified2025-05-19
Reported by FDA2025-05-28
Terminated2026-02-19
DistributedDE, NC
Quantity391,680 tubes
Reason classescgmp
NDC53247-0132-02
Lot numbersB0009, B0017, B0018, B0019, B0036, B0037, B0038, B0049, B0063
Expiration dates2026-05-31, 2026-06-30, 2026-07-31, 2026-08-31

Product

Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02

Reason for recall

CGMP Deviations

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0431-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.