Use caution Drug recall · FDA · Published October 17, 2024

Keystone Recalls Perio Maintenance Rinse Due to Subpotent Drug Hazard

Keystone Industries recalls Perio Maintenance Rinse (Mint) because the drug may be subpotent. Check lot numbers PVC-003015 and PVC-003061.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0046-2025Drug Keystone Industries ›

Use caution until it’s fixed

Subpotent Drug

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Contact the company

Recalling firmKeystone Industries480 S Democrat Rd · Gibbstown, NJ 08027-1239

✎ GovInfoNow plain-language explainer

Keystone Industries is recalling Perio Maintenance Rinse, a 0.63% Stannous Fluoride Concentrated Solution in Mint flavor, because it is classified as a subpotent drug. This means the product may not contain the correct amount of active ingredient to be effective. The recall affects 787 pumps distributed nationwide within the United States. Read more at govinfonow.com/recall/32506-keystone-recalls-perio-maintenance-rinse-due-to-subpotent-drug-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/32506-keystone-recalls-perio-maintenance-rinse-due-to-subpotent-drug-hazard · Updated October 9, 2026 · FDA enforcement record: FDA #D-0046-2025

Cite this page

“Keystone Recalls Perio Maintenance Rinse Due to Subpotent Drug Hazard.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32506-keystone-recalls-perio-maintenance-rinse-due-to-subpotent-drug-hazard. Based on FDA recall #D-0046-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0046-2025%22&limit=1).

The FDA announced on Oct. 17, 2024, that Keystone Industries is recalling Perio Maintenance Rinse due to subpotent drug risks. Owners should contact the company for a refund.

How to tell if you have it

Brand: Keystone Industries
Product: Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint
NDC: 68400-202-10
Lot codes: PVC-003015, Exp. Date Sep-21-2025; PVC-003061, Exp. Date Apr-30-2026

The hazard

The product is classified as a subpotent drug. The FDA said the recall addresses this hazard.

Context

GovInfoNow's records show Keystone Industries has issued five other recalls since April 10, 2023. Other recent recalls of similar products include Gasco Isopropyl Alcohol 70% Recall (May 29, 2026), Gasco Industrial Isopropyl Alcohol 70% Recall (May 29, 2026), and Specialty Process Labs Thyroid Product Recall (Jan. 16, 2026).

How to tell if you have this one

Check your bottle for the brand name 'Perio Maintenance Rinse' and the flavor 'Mint'. Verify the NDC number (68400-202-10) and look for one of the following lot numbers: PVC-003015 with an expiration date of Sep-21-2025, or PVC-003061 with an expiration date of Apr-30-2026.

Brand
Keystone Industries
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Product Details
Verify if your bottle matches the recalled lot numbers (PVC-003015 or PVC-003061) and expiration dates.
Contact Keystone Industries
Reach out to the manufacturer for further instructions on how to proceed with the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 34 days after the firm started it.

Oct 17, 2024Firm started the recall
Nov 14, 2024FDA classified it Class II
Nov 20, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Keystone Industries recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32506-keystone-recalls-perio-maintenance-rinse-due-to-subpotent-drug-hazard">Keystone Recalls Perio Maintenance Rinse Due to Subpotent Drug Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0046-2025 (October 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0046-2025 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.