Perio Maintenance Rinse Recalled for Subpotent Stannous Fluoride Concentration
Keystone Industries is recalling Perio Maintenance Rinse due to subpotency—the stannous fluoride concentration is below specifications. Affected lots were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary Class II recall for a subpotent drug—an efficacy issue rather than an acute safety hazard. No illnesses or injuries have been reported. Voluntary recalls without reported harm typically score 2 per the rubric.
Plain-English summary
Keystone Industries is voluntarily recalling Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, a prescription-only oral rinse, due to subpotency. The stannous fluoride concentration in certain lots is below the required specification.
The recall affects 787 pumps distributed nationwide within the United States. Two lot numbers are involved: PVC-003015 (expiring Sep-21-2025) and PVC-003061 (expiring Apr-30-2026). The firm initiated this recall voluntarily on October 17, 2024.
Consumers and healthcare providers with these products should contact Keystone Industries or consult their healthcare provider. No illnesses or injuries have been reported in connection with this product.
The recalled product
- 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
- Manufacturer
- Keystone Industries
- Category
- Drug — Periodontal rinse
- Hazard
- Affected units
- 787
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: PVC-003015
- Exp. Date Sep-21-2025
- PVC-003061
- Exp. Date Apr-30-2026
Distribution
Distributed nationwide across the United States.
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