Bayer Healthcare Pharmaceuticals recalls
Bayer Healthcare Pharmaceuticals appears in 30 official U.S. recall notices indexed by RecallRadar, most recently on 2023-12-06.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 30 |
|---|---|
| Published | 2012-08-08 to 2023-12-06 |
| By agency | FDA Drug (30) |
| By classification | Class II (16), Class I (10), Class III (4) |
| By status | terminated (30) |
| Distribution named in notices | AR, CA, KS, NY, PR, US |
Recalls
- VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany,…
FDA Drug · Class I · 2023-12-06 · Bayer Healthcare Pharmaceuticals
Reason: Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing - LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Pro…
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. - Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a) Product of Ireland 86940418, (b)Product of Finland 20006106,…
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. - Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418
FDA Drug · Class I · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: Chemical Contamination: presence of benzene - LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Pr…
FDA Drug · Class I · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: Chemical Contamination: presence of benzene - LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Pro…
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. - Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Irel…
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. - Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897,…
FDA Drug · Class I · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: Chemical Contamination: presence of benzene - LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, UPC 0 41100 58720 6, NDC 11523-0010-2
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facility where other lots were found to be contaminated with benzene. - 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…
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. - Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of…
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. - Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ…
FDA Drug · Class I · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: Chemical Contamination: presence of benzene - LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 160g (5.6 OZ) can, packaged as (a) single pack, UPC 0 41100 587…
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. - LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of…
FDA Drug · Class I · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: Chemical Contamination: presence of benzene - Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41…
FDA Drug · Class I · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: Chemical Contamination: presence of benzene - Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finl…
FDA Drug · Class I · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: Chemical Contamination: presence of benzene - LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981,…
FDA Drug · Class I · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: Chemical Contamination: presence of benzene - 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…
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. - LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 0…
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. - Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897,…
FDA Drug · Class II · 2021-11-24 · Bayer Healthcare Pharmaceuticals
Reason: cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. - All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton
FDA Drug · Class I · 2018-05-02 · Bayer Healthcare Pharmaceuticals
Reason: 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… - Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bay…
FDA Drug · Class II · 2018-03-14 · Bayer Healthcare Pharmaceuticals
Reason: Labeling: Label mix-up - Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962…
FDA Drug · Class III · 2018-01-03 · Bayer Healthcare Pharmaceuticals
Reason: Failed Stability Specifications - Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervesc…
FDA Drug · Class II · 2017-08-09 · Bayer Healthcare Pharmaceuticals
Reason: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. - Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Efferve…
FDA Drug · Class II · 2017-08-09 · Bayer Healthcare Pharmaceuticals
Reason: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. - Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent…
FDA Drug · Class II · 2017-08-09 · Bayer Healthcare Pharmaceuticals
Reason: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs. - 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 85g (UPC 041100811…
FDA Drug · Class III · 2017-03-29 · Bayer Healthcare Pharmaceuticals
Reason: Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue. - Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg)…
FDA Drug · Class III · 2013-07-24 · Bayer Healthcare Pharmaceuticals
Reason: Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point. - Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 9810…
FDA Drug · Class III · 2013-02-13 · Bayer Healthcare Pharmaceuticals
Reason: Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point. - Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art
FDA Drug · Class II · 2012-08-08 · Bayer Healthcare Pharmaceuticals
Reason: Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.