An investigation by Kaiser Health News into thousands of recent drug recalls reveals a frightening record of medicines in the US being tainted with dangerous bacteria, mold, glass shards, rubber bits, cancer-causing chemicals, mysterious powders, and worrying metal particles. There were also cases of medications with too much or too little ingredients—or simply the wrong ingredients entirely.
Digging deeper, the investigation discovered that a startling number of the drug makers who issued the recalls had received an all-clear from Food and Drug Administration inspectors within a year of their recalls. FDA records and lawsuits suggest that drug makers can easily game the inspection system, mislead inspectors, lie about where drugs are manufactured, or outright sabotage inspections.
For instance, FDA enforcement documents reveal that employees at one drug-making facility in Japan stood “shoulder-to-shoulder” to physically block an FDA inspector from looking around, and another drug maker in India faked a worker strike and cut the lights at its facility to foil an inspection. In a different case, whistleblowers alleged in a lawsuit that Gilead Sciences told the FDA that it used a facility in South Korea to make an ingredient for HIV drugs Truvada and Atripla, but in reality, Gilead was using an unregistered facility in China. The civil suit claimed that the Chinese ingredient contained “glass-like shards,” “black rubber-like particles,” “plastic-like particles,” “small stone or pebble-like particles” and “metal shards.”