Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

24 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2012 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Hillyard

Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.

Terminated Microbial contamination Hillyard GMP NDC 76402-403-03 D-140-2013
Class II · Moderate risk

12-Hour Sinus

Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.

Terminated Microbial contamination Lee Pharmaceuticals, Inc NDC 68016-0307-03 D-161-2013
Class II · Moderate risk

Limed Bone Gelatin

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination American Enterprises LLC dba Sterling Gelatin D-062-2013
Class II · Moderate risk

UP & UP brand

Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.

Terminated Microbial contamination DermaCare, Inc. D-035-2013
Class II · Moderate risk

UP & UP brand

Microbial Contamination of Non-Sterile Products: Laboratory findings of high total plate count above specification.

Terminated Microbial contamination DermaCare, Inc. D-034-2013
Class II · Moderate risk

DRxChoice Fiber Capsules

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. D-032-2013
Class II · Moderate risk

Premier Value Fiber Capsules

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. D-030-2013
Class II · Moderate risk

Simply Right Healthcare Fiber Capsules

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. D-029-2013
Class II · Moderate risk

Berkley & Jensen Fiber Capsules

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. D-028-2013
Class II · Moderate risk

Wal-Mucil Plus Calcium Fiber Capsules

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. NDC 0363-0128-24 D-027-2013
Class II · Moderate risk

Wal-Mucil 100% Natural Fiber

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. D-026-2013
Class II · Moderate risk

Up&Up Psyllium Fiber Supplement

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. NDC 11673-059-87 D-025-2013
Class II · Moderate risk

Leader Fiber Capsules

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. NDC 37205-372-78 D-024-2013
Class II · Moderate risk

Equate Fiber Therapy

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. NDC 68163-119-60 D-023-2013
Class II · Moderate risk

Best Choice Health Care

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Terminated Microbial contamination Raritan Pharmaceuticals, Inc. D-021-2013
Class II · Moderate risk

ZEE Antiseptic Wipes

Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)

Terminated Microbial contamination Dukal Corp. D-1675-2012
Class II · Moderate risk

Kleenex Foam Hand Sanitizer

Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.

Terminated Microbial contamination Kimberly-Clark Corporation D-1415-2012
Class II · Moderate risk

Kleenex Luxury Foam Hand Sanitizer

Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.

Terminated Microbial contamination Kimberly-Clark Corporation D-1414-2012

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