Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution recall
FDA recall D-0046-2025 · initiated Oct 17, 2024
Keystone Industries recalled Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution in Oct 2024 — an FDA Class II recall (D-0046-2025) because Subpotent Drug.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 787 pumps
Details
- 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
- Recalling company
- Keystone Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Oct 17, 2024
- FDA report date
- Nov 20, 2024
Frequently asked
- Was Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution recalled?
- Keystone Industries recalled Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution in Oct 2024 — an FDA Class II recall (D-0046-2025) because Subpotent Drug. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0046-2025 was: Subpotent Drug
- Is a recalled Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0046-2025.