Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Microbial contamination

Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection.

1,002 FDA drug recalls with this cause, newest first.

These recalls involve bacteria, mold, yeast or other microorganisms actually found in the finished product. This overlaps with sterility issues but is tracked separately because it usually points to a specific breakdown - a water system, an unsealed container, a contaminated raw material - rather than a general process failure. It carries a large share of Class I recalls: an organism such as Burkholderia cepacia or Pseudomonas in an eye drop, nasal spray or oral liquid can cause serious infection.

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 III · Low risk

Oasis Age Essential

Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.

Terminated Microbial contamination Natural Essentials Inc D-1671-2012
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