Maximum Security — Class II drug recall D-0434-2025
Terminated recall by KENIL HEALTHCARE PRIVATE LIMITED, reported 2025-05-28, distributed in DE, NC. CGMP Deviations
| Recall number | D-0434-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KENIL HEALTHCARE PRIVATE LIMITED, Ta. Kadi, District Mehsana, N/A, India |
| Recall initiated | 2025-04-24 |
| Classified | 2025-05-19 |
| Reported by FDA | 2025-05-28 |
| Terminated | 2026-02-19 |
| Distributed | DE, NC |
| Quantity | 216,720 tubes |
| Reason classes | cgmp |
| NDC | 53247-0132-04 |
| Lot numbers | B0013, B0018, B0053, B0054, B0090, B0091, B0092, B0093, B0094, B0095, B0096, B0097, B0098, B0099, B0100, B0101 |
| Expiration dates | 2026-05-31, 2026-06-30, 2026-07-31, 2026-09-30 |
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
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-0434-2025. 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.