Bayer HealthCare Pharmaceuticals Inc.
Complete recall history across all FDA and CPSC categories — 23 total recalls
Bayer HealthCare Pharmaceuticals Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (23)
FDA drug safety enforcement actions by Bayer HealthCare Pharmaceuticals Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 6, 2023 | VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manu... | Microbial Contamination of Non-Sterile Products: microbial contamination iden... | Class I |
| Oct 1, 2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can,... | Chemical Contamination: presence of benzene | Class I |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist... | cGMP Deviations: manufactured at the same facility where other lots were foun... | Class II |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, Labeled as (a... | cGMP Deviations: manufactured at the same facility where other lots were foun... | Class II |
| Oct 1, 2021 | Lotrimin AF (Miconazole nitrate 2%) Liquid Spray NET WT 133g (4.6 oz) can, P... | cGMP Deviations: manufactured at the same facility where other lots were foun... | Class II |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Powder Spray NET WT 133g (4.6 OZ) can, pa... | cGMP Deviations: manufactured at the same facility where other lots were foun... | Class II |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist... | Chemical Contamination: presence of benzene | Class I |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, labeled as (a)... | cGMP Deviations: manufactured at the same facility where other lots were foun... | Class II |
| Oct 1, 2021 | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 1... | cGMP Deviations: LOTRIMIN AF (Tolnaftate 1%) manufactured at the same facilit... | Class II |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 O... | cGMP Deviations: manufactured at the same facility where other lots were foun... | Class II |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dis... | Chemical Contamination: presence of benzene | Class I |
| Oct 1, 2021 | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray, NET WT 1... | cGMP Deviations: manufactured at the same facility where other lots were foun... | Class II |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 ... | Chemical Contamination: presence of benzene | Class I |
| Oct 1, 2021 | LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 13... | cGMP Deviations: manufactured at the same facility where other lots were foun... | Class II |
| Oct 1, 2021 | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 1... | Chemical Contamination: presence of benzene | Class I |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 O... | cGMP Deviations: manufactured at the same facility where other lots were foun... | Class II |
| Oct 1, 2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4... | Chemical Contamination: presence of benzene | Class I |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, lab... | cGMP Deviations: manufactured at the same facility where other lots were foun... | Class II |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a... | Chemical Contamination: presence of benzene | Class I |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a... | Chemical Contamination: presence of benzene | Class I |
| Jun 13, 2013 | Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingre... | Failed Stability Specifications: Out of specification results for particle si... | Class III |
| May 31, 2012 | Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, ... | Impurities/Degradation Products: A confirmed out of specification result for ... | Class III |
| May 8, 2012 | Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg ... | Cross Contamination w/Other Products: This active pharmaceutical ingredient i... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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