Equate Tartar Control Plus Mouthwash Recalled for Out-of-Specification Formula
Walmart is recalling Equate Tartar Control Plus mouthwash from certain lots because they were found to have active ingredients outside the approved specification.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for active ingredients found outside the approved specification. No illnesses or injuries have been reported, but the formulation issue represents a potential risk of harm from improper ingredient levels.
Plain-English summary
Equate Tartar Control Plus Antiseptic Mouthwash (Blue Mint, 1.5 liter bottles) is being recalled by Vi-Jon, LLC, the manufacturer, and Walmart, the distributor.
The recall was initiated after a product complaint regarding the milky blue appearance and consistency of the mouthwash. Further investigation found that the affected lots contained active ingredients (eucalyptol, menthol, methyl salicylate, and thymol) that were out of specification.
The recall affects approximately 75,064 bottles sold nationwide in the United States. The affected lot numbers are 0559696 and 0563041, with an expiration date of February 2024. The product has a UPC of 681131148009.
Consumers who purchased these products should stop using them and contact the retailer for a refund or return instructions.
The recalled product
- Product
- Equate Tartar Control Plus (Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%) Antiseptic Mouthrise Plus, Antigingivitis/Antiplaque, Blue Mint, 1.5 Liter (50.7 FL OZ) bottle, Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716, UPC 6 81131 14800…
- Manufacturer
- Vi-Jon, LLC
- Category
- Drug — Oral Care / Mouthwash
- Affected units
- 75,064
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 (3)
- Lots: 0559696
- 0563041
- Exp. 02/2024
Distribution
Distributed nationwide across the United States.
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