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Bayer Healthcare Pharmaceuticals Recalls
30 recalls on record · August 8, 2012 to December 6, 2023 · Drugs
Recalls by year
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17
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21
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 6, 2023DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceutica
Hazard: Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC
Hazard: cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 079
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, N
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC,
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whi
Hazard: Chemical Contamination: presence of benzene
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 079
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product o
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, Packaged as (a) single pack, UPC 0 41100 407
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pa
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, packaged as (a) a single pack NDC 11523-0544-
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whip
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
November 24, 2021DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whip
Hazard: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
May 2, 2018DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton
Hazard: Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
March 14, 2018DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bo
Hazard: Labeling: Label mix-up
January 3, 2018DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Mo
Hazard: Failed Stability Specifications
August 9, 2017DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbon
Hazard: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
August 9, 2017DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Cit
Hazard: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
August 9, 2017DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric
Hazard: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
March 29, 2017DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz
Hazard: Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
July 24, 2013DrugsFDA
Bayer HealthCare Pharmaceuticals Inc. recalls Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (l
Hazard: Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
February 13, 2013DrugsFDA
Bayer HealthCare Pharmaceuticals Inc. recalls Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, L
Hazard: Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
August 8, 2012DrugsFDA
Bayer HealthCare Pharmaceuticals Inc. recalls Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Baye
Hazard: Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.