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 I · High risk

Sinus Relief

Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.

Terminated Microbial contamination Product Quest Manufacturing LLC D-0074-2019
Class II · Moderate risk

Mushatt's No. 9

Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.

Terminated Microbial contamination Product Quest Manufacturing LLC D-0072-2019