Perio Maintenance Rinse 0 — Class II drug recall D-0046-2025
Ongoing recall by Keystone Industries, reported 2024-11-20, distributed nationwide. Subpotent Drug
| Recall number | D-0046-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Industries, Gibbstown, NJ, United States |
| Recall initiated | 2024-10-17 |
| Classified | 2024-11-14 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 787 pumps |
| Reason classes | potency |
| NDC | 68400-0202-10 |
| Lot numbers | APR-30-2026, PVC-003015, PVC-003061, SEP-21-2025 |
Product
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10
Reason for recall
Subpotent Drug
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-0046-2025. 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.