More than 80,000 bottles of Parodontax mouthwash are being recalled across the United States after labels were found missing lot numbers and expiration dates, federal regulators said. The Food and Drug Administration classified the action as a Class III recall, signaling an issue that is not expected to cause adverse health consequences. The recall affects products distributed nationwide and centers on traceability and consumer guidance concerns.
“Over 80,000 bottles of Parodontax mouthwash recalled nationwide due to missing lot numbers and expiration dates, FDA announces Class III recall for safety.”
The recall addresses a labeling error rather than a contamination or formulation problem. Products missing lot and date information can complicate tracking, stock rotation, and consumer decisions, especially when identifying expired items. Regulators said the omission triggered the least serious recall category, but urged retailers and consumers to verify packaging before use.
What the recall covers
The affected items are Parodontax-branded mouthwash bottles sold in the U.S. market. The reported issue is the absence of the lot code and expiration date on the labels. Those details are standard on over-the-counter products to enable tracking through the supply chain and to guide safe use at home.
Class III recalls typically involve labeling or minor compliance issues. They do not indicate a known risk of serious harm. In this case, the omission limits the ability to confirm shelf life and identify specific batches if future quality updates are needed.
Why a Class III recall matters
FDA recall classes reflect expected health impact. Class I is the most serious, Class II indicates a temporary or reversible risk, and Class III covers issues unlikely to cause adverse health consequences. The Parodontax mouthwash action falls into the latter category.
Even so, missing lot and date details can affect recall efficiency. Without a lot code, distributors and retailers have a harder time isolating affected units. Consumers also rely on expiration dates to judge product freshness and effectiveness.
Labeling errors and traceability
Labeling accuracy is part of federal rules for nonprescription products. Lot codes allow manufacturers to trace production runs, manage inventory, and respond quickly to quality reports. Expiration dates help consumers avoid using a stale product that may not perform as intended.
FDA data indicate that labeling problems are a frequent reason for over-the-counter product recalls. While these events usually do not signal a safety hazard, they can slow recall logistics and cause confusion at the point of sale.
Guidance for consumers and retailers
- Check your Parodontax mouthwash bottle for a printed lot number and expiration date.
- If either item is missing, set the product aside and follow retailer return or disposal instructions.
- Do not rely on guesswork about freshness; request a replacement with full labeling.
- Retailers should review shelf stock and backroom inventory and remove units lacking the required information.
Consumers who have used the mouthwash should not expect health issues solely because of the label omission. The Class III designation signals low risk. Anyone with concerns about product quality or adverse reactions should consult a healthcare professional and report issues to the manufacturer or FDA’s MedWatch program.
Company and market context
Parodontax is known for oral-care products sold in pharmacies and mass retailers. Mouthwash labels must meet the same federal standards that apply across the over-the-counter category. When labeling lapses occur, companies typically coordinate with distributors to retrieve affected stock and replace it with correctly labeled units.
Industry experts say these corrections serve two goals: protect consumer trust and preserve traceability for future quality reviews. While the recall volume—more than 80,000 bottles—is sizable, the absence of a health hazard classification suggests the issue is administrative rather than formulation-related.
What to watch next
Key next steps include how quickly recalled units are removed and replaced, and whether the company updates packaging controls to prevent repeat errors. Retail execution will likely determine how many unlabeled bottles remain in circulation.
For consumers, the takeaway is simple: verify the lot code and expiration date on mouthwash bottles before purchase and use. For retailers and distributors, prompt shelf checks and clear signage can reduce confusion and help ensure compliant stock reaches customers.
The recall highlights a basic rule of over-the-counter products: accurate labels are not just paperwork. They help track quality, guide safe use, and keep recalls efficient when issues arise. The FDA’s Class III action signals limited risk, but swift compliance will restore full traceability and consumer confidence.
