The Recall Desk

Manufacturer

Bayer HealthCare Pharmaceuticals, Inc.

30 recalls in our database name Bayer HealthCare Pharmaceuticals, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
30
Critical
0
Severe
15
Most recent
2023-12-06

Of the 30 recalls from Bayer HealthCare Pharmaceuticals, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 15 (50%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 30

  • SevereFDA (Drugs)·D-0145-2024·2023-12-06

    Prescription drug oral solution recalled for microbial contamination

    Bayer Healthcare Pharmaceuticals Inc. is recalling 192 bottles of VITRAKVI (larotrectinib) oral solution due to microbial contamination identified as Penicillium brevicompactum during routine testing.

    Product
    VITRAKVI — VITRAKVI (LAROTRECTINIB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0244-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0248-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0246-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0253-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0251-2022·2021-11-24

    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 — TINACTIN (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0242-2022·2021-11-24

    Tinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray due to potential benzene contamination. The product was manufactured at a facility where other lots tested positive for benzene.

    Product
    TINACTIN — TINACTIN (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0247-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0236-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0249-2022·2021-11-24

    Lotrimin Daily Prevention Deo Tolnaftate Spray Recalled for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Lotrimin Daily Prevention Deo (Tolnaftate 1%) spray powder due to the presence of benzene contamination. The recall affects 579,456 cans distributed nationwide.

    Product
    LOTRIMIN DAILY PREVENTION DEO — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0250-2022·2021-11-24

    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 — TINACTIN (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0252-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0239-2022·2021-11-24

    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 — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0240-2022·2021-11-24

    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 — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0243-2022·2021-11-24

    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 — TINACTIN (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0245-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0237-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0241-2022·2021-11-24

    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
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0254-2022·2021-11-24

    Lotrimin Daily Prevention Deo Tolnaftate Spray Recalled for Potential Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF Daily Prevention deodorant powder spray due to cGMP deviations at the manufacturing facility where other lots were found contaminated with benzene.

    Product
    LOTRIMIN DAILY PREVENTION DEO — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0697-2018·2018-05-02

    Bayer Recalls Alka-Seltzer Plus Packages Due to Ingredient Label Mismatch

    Bayer is recalling specific Alka-Seltzer Plus packages because the ingredients listed on the front sticker may not match the actual product inside the carton.

    Product
    All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or g
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0590-2018·2018-03-14

    Bayer Recalls Coppertone Kids Sunscreen Spray Due to Labeling Error

    Bayer HealthCare Pharmaceuticals is recalling 528 bottles of Coppertone Kids Sunscreen Spray in Arkansas due to a label mix-up.

    Product
    Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0135-2018·2018-01-03

    Bayer Chewable Low Dose Aspirin Recalled for Failed Stability Specifications

    Bayer HealthCare Pharmaceuticals is recalling 104,128 bottles of Chewable Low Dose Aspirin 81 mg due to failed stability specifications.

    Product
    Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1044-2017·2017-08-09

    Bayer Recalls Alka-Seltzer Tablets Due to Defective Blister Pack Foil

    Bayer HealthCare is recalling Alka-Seltzer Original effervescent tablets because customer complaints confirmed small holes or cracks in the foil of the blister packs.

    Product
    Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1050-2017·2017-08-09

    Bayer Recalls Alka-Seltzer Extra Strength Tablets Due to Defective Packaging

    Bayer is recalling Alka-Seltzer Extra Strength effervescent tablets because customer complaints confirmed small holes or cracks in the foil blister packs.

    Product
    Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Bayer HealthCare Pharmaceuticals

American subsidiary of Bayer HealthCare

Founded
2006
Parent company
Bayer

Official website

Source: Wikidata (Q3935683), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.