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Bayer Healthcare Pharmaceuticals Inc.

Bayer Healthcare Pharmaceuticals Inc. Recalls

All product recalls associated with Bayer Healthcare Pharmaceuticals Inc..

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Recall Summary

Total Recalls

1000

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 721–740 of 2399 recalls

Tinactin Deodorant Powder (Bayer) – Manufacturing Deviation (2021)

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

Class IIModerate

FDAOct 1, 2021Nationwide• Bayer Healthcare Pharmaceuticals Inc.

Tinactin Jock Itch Powder Spray (Bayer) - Benzene Contamination (2021)

Chemical Contamination: presence of benzene

Class IHigh

FDAOct 1, 2021Nationwide• Bayer Healthcare Pharmaceuticals Inc.

LOTRIMIN AF Daily Prevention Spray (Bayer) - Manufacturing Deviation (2021)

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

1...35 363738 39...120

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Class II

Moderate

FDAOct 1, 2021Nationwide• Bayer Healthcare Pharmaceuticals Inc.

LOTRIMIN AF Deodorant Powder Spray (Bayer) - Benzene Contamination (2021)

Chemical Contamination: presence of benzene

Class IHigh

FDAOct 1, 2021Nationwide• Bayer Healthcare Pharmaceuticals Inc.

LOTRIMIN AF Daily Prevention Spray (Bayer) - Manufacturing Deviation (2021)

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

Class IIModerate

FDAOct 1, 2021Nationwide• Bayer Healthcare Pharmaceuticals Inc.

LOTRIMIN AF Powder Spray (Bayer) - Manufacturing Deviation (2021)

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

Class IIModerate

FDAOct 1, 2021Nationwide• Bayer Healthcare Pharmaceuticals Inc.

Tinactin Powder Spray (Bayer) - Manufacturing Deviation (2021)

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

Class IIModerate

FDAOct 1, 2021Nationwide• Bayer Healthcare Pharmaceuticals Inc.

Tinactin Jock Itch Powder Spray (Bayer) - Manufacturing Deviation (2021)

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

Class IIModerate

FDAOct 1, 2021Nationwide• Bayer Healthcare Pharmaceuticals Inc.

Becton Dickinson Infusion Therapy Systems Inc.: BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/...

There is a breach in the product packaging that renders the product non-sterile.

FDASep 8, 2021Nationwide• Becton Dickinson Infusion Therapy Systems Inc.

Roche Molecular Systems, Inc.: cobas EGFR Mutation Test v2-Somatic gene mutation detecti...

False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment

FDASep 3, 2021Nationwide• Roche Molecular Systems, Inc.

Donepezil HCL Tablets (Jubilant Cadista) – Subpotent Medication (2021)

Subpotent

Class IIILow

FDAAug 20, 2021Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Roche Molecular Systems, Inc.: cobas SARS-CoV-2 & Influenza A/B Test for use on the coba...

Customers have reported an increased number of false positive SARS-CoV-2 results.

FDAAug 4, 2021Nationwide• Roche Molecular Systems, Inc.

Dark Chocolate Malt Balls (DSD Merchandisers) – Undeclared Peanuts (2021)

Undeclared Nuts

Firm notified by customers that product labeled as Dark Chocolate Malt Balls had Dark Chocolate Peanut Butter malt balls inside - undeclared peanuts.

Class IHigh

FDAAug 4, 2021CA, HI• DSD Merchandisers, Inc.

Fresenius Medical Care Holdings, Inc.: AquaBplus Water Purification System, Part Number 24-2000-...

AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation

FDAAug 3, 2021Nationwide• Fresenius Medical Care Holdings, Inc.

Magnolia Medical Technologies, Inc.: Steripath Luer Transport Pack, Gen2, Luer, BD - Product U...

Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).

FDAAug 2, 2021Nationwide• Magnolia Medical Technologies, Inc.

Clopidogrel Tablets (Macleods) – Foreign Matter (2021)

Presence of foreign matter

Class IIModerate

FDAAug 2, 2021Nationwide• Macleods Pharma Usa Inc

Ethosuximide Oral Solution (PAI Holdings) – CGMP Violation (2021)

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Class IIModerate

FDAJul 29, 2021Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Cimetidine Hydrochloride (PAI Holdings) – CGMP Violation (2021)

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Class IIModerate

FDAJul 29, 2021Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Nystatin Oral Suspension (PAI) – Potential Senna Carryover (2021)

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Class IIModerate

FDAJul 29, 2021Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Roche Diabetes Care, Inc.: Accu-Chek Inform II Test Strip, Whole Blood Glucose Test ...

Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.

FDAJul 28, 2021Nationwide• Roche Diabetes Care, Inc.