parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02
USparodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02
Recalling Firm: Haleon US Holdings LLC
Motif du rappel / Danger
TranslatedLabeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
Description du produit & Identification
Translatedparodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02
Additional Source Details
| Field | Value |
|---|---|
| City | Warren |
| State | NJ |
| Openfda › Unii | D9OM4SK49P |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 1100924 |
| Openfda › Spl id | 34a4093a-3aa9-3c7b-e063-6294a90a961a |
| Openfda › Brand name | PARODONTAX |
| Openfda › Spl set id | 444f931d-5e38-4cda-97ba-98aa0b5fe4f6 |
| Openfda › Package ndc › 1 | 0135-0651-02 |
| Openfda › Package ndc › 2 | 0135-0651-03 |
| Openfda › Package ndc › 3 | 0135-0650-01 |
| Openfda › Product ndc › 1 | 0135-0650 |
| Openfda › Product ndc › 2 | 0135-0651 |
| Openfda › Generic name | CETYLPYRIDINIUM CHLORIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | CETYLPYRIDINIUM CHLORIDE |
| Openfda › Manufacturer name | Haleon US Holdings LLC |
| Openfda › Application number | M022 |
| Openfda › Is original packager | true |
| Event id | 98198 |
| Address 1 | 184 Liberty Corner Rd Ste 200 |
| Address 2 | N/A |
| Code info | Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle. |
| Postal code | 07059-6870 |
| Report date | 20260204 |
| Product type | Drugs |
| Product quantity | 84,764 bottles |
| Reason for recall | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251226 |
| Initial firm notification | Letter |
| Center classification date | 20260126 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by H...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Aperçu
- Entreprise responsableHaleon US Holdings LLC
- StatusOngoing
- Niveau de risqueClass III
- DistributionNationwide in the USA
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🚨 SAFETY ALERT: Haleon US Holdings LLC - parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02 Check if your household is affected: https://therecallfile.com/fr/recalls/parodontax-cetylpyridinium-chloride-active-gum-health-mouthwash-mint-n/FDA-D-0297-2026
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