Blistex Spray
FDA Recall NDC 10157-4645
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Blistex (NDC 10157-4645). A significant event, classified as Class I, was initiated on Nov 17, 2021 by Blistex Inc. The reported reason for this action was: "Chemical contamination: Presence of benzene"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Chemical contamination: Presence of benzene
Nov 17, 2021
Dec 27, 2023
243,386 cases (7 6-pack cases; 36 12-pack cases; 2,678,430 cans total)
Recall Profile & Regulatory Data
Event ID
89055
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Blistex Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide with the USA, Canada and Korea
Termination Date
Jul 18, 2024
Product Description
Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392.
Batch or Lot Expiration Information
Lot# a)
Lot# : D19K22, D19K23, Exp. Date 10/21; D19M24, D19M25, D19M26, D19M27, Exp. Date 12/21; D20C01, D20C02, D20C03, D20C04, Exp. Date 3/22; D20F08, D20F09, Exp. Date 6/22; LD20H10, D20H11, Exp. Date 8/22; D20K13, D20K14, Exp. Date 10/22 D21B01, Exp. Date 2/23; D21D03, Exp. Date 4/23; D21E04, D21F04, Exp. Date 5/23; D21F05, Exp. Date 6/23; D21G01, D21G02, Exp. Date 7/23; D21H03, D21H04, D21H05, Exp. Date 8/23. b)
Lot# : D19M27, D19M28, D19M29, D19M30, Exp. Date 12/21; D20E05, D20E06, D20E07, Exp. Date 5/22; D20M15, D20M16, Exp. Date 12/22; D21B02, Exp. Date 2/23
Affected Packages Involved in this Recall
10157-4645-1Product
10157-4645-2Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
