The Recall Desk

FDA (Drugs) recall action 88677

Bayer Healthcare Pharmaceuticals Inc. recalled 19 products on 2021-11-24

The FDA (Drugs) publishes a recall like this one as 19 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 19 pages.

Products
19
Announced
2021-11-24
Critical
0
Units
44,302,392

Why these products were recalled

Chemical Contamination: presence of benzene

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–19 of 19

  • SevereFDA (Drugs)··2021-11-24

    Lotrimin AF Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare is recalling Lotrimin AF miconazole nitrate 2% powder spray due to the presence of benzene chemical contamination. The recall affects approximately 3.8 million cans distributed nationwide.

    Product
    LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2021-11-24

    Lotrimin Daily Prevention Deo recalled for potential benzene contamination

    Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found contaminated with benzene.

    Product
    LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-11-24

    Lotrimin AF Deodorant Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare is recalling Lotrimin AF Deodorant Powder Spray (Miconazole nitrate 2%) nationwide due to the presence of benzene contamination. The recall affects approximately 2.8 million cans distributed across the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2021-11-24

    Lotrimin Daily Prevention Deo Spray Recalled for Benzene Contamination Risk

    Bayer Healthcare Pharmaceuticals is recalling Lotrimin Daily Prevention Deo (Tolnaftate) spray due to potential benzene contamination from manufacturing facility cGMP deviations. The product was distributed nationwide and internationally.

    Product
    LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-11-24

    LOTRIMIN AF Powder Spray Recalled for Benzene Contamination Risk

    Bayer Healthcare is recalling LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray because it was manufactured at a facility where other lots were found contaminated with benzene. The recall affects multiple lot numbers distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-2 UPC 3 11017 41025 7; (b) 3 pack, NDC 11523-0544-2, UPC 0 41100 58594 3; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, ,
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2021-11-24

    Lotrimin AF Liquid Spray Recalled for Potential Benzene Contamination

    Bayer Healthcare is recalling Lotrimin AF Miconazole nitrate 2% Liquid Spray nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to contain benzene.

    Product
    Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 40788 7, NDC 11523-4327-1; (b) 3-pack UPC 0 41100 58593 6; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-11-24

    Tinactin Tolnaftate Powder Spray Recalled Due to Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) Powder Spray because some cans contain benzene contamination. Consumers should stop using affected lots and consult a healthcare provider.

    Product
    Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-11-24

    Tinactin Tolnaftate Liquid Spray Recalled for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) liquid spray due to the presence of benzene chemical contamination. The product was distributed nationwide through retail channels.

    Product
    TINACTIN (TOLNAFTATE)
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-11-24

    LOTRIMIN AF Miconazole Nitrate Powder Spray Recall for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling LOTRIMIN AF Jock Itch Powder Spray (4.6 oz, Miconazole Nitrate 2%) because certain lots contain benzene, a chemical contaminant.

    Product
    LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-11-24

    LOTRIMIN AF Miconazole Nitrate Powder Spray Recalled for Benzene Contamination

    Bayer is recalling LOTRIMIN AF Deodorant Powder Spray due to potential benzene contamination from manufacturing deviations at a facility where other lots were found contaminated. The recall affects 2,817,468 cans distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-11-24

    Tinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray due to the presence of benzene chemical contamination. The recall affects 738,432 cans distributed nationwide and internationally.

    Product
    TINACTIN (TOLNAFTATE)
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2021-11-24

    LOTRIMIN AF Jock Itch Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare is recalling LOTRIMIN AF Jock Itch Powder Spray (Miconazole nitrate 2%, 4.6 OZ cans) distributed nationwide due to manufacturing facility cGMP deviations where other lots were found to be contaminated with benzene.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2021-11-24

    Tinactin Tolnaftate Spray Recalled for Potential Benzene Contamination

    Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) liquid spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.

    Product
    TINACTIN (TOLNAFTATE)
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-11-24

    Tinactin Tolnaftate Jock Itch Powder Spray Recall Due to Benzene Contamination

    Bayer Healthcare is recalling Tinactin Tolnaftate 1% Jock Itch Powder Spray due to the presence of benzene contamination. The product was distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2021-11-24

    Tinactin Tolnaftate Powder Spray Recalled for Potential Benzene Contamination

    Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) Powder Spray due to potential benzene contamination from cGMP deviations at the manufacturing facility. The recall affects approximately 2.8 million cans distributed nationwide and internationally.

    Product
    Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106, (c) Product of Ireland with Instant redeemable coupon ( IRC); Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2021-11-24

    Tinactin Jock Itch Powder Spray Recall Due to Benzene Contamination

    Bayer Healthcare is recalling 592,416 cans of Tinactin (Tolnaftate 1%) Jock Itch Powder Spray distributed nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.

    Product
    Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5
    Category
    Distribution
    1 state