Mylan has expanded the recall of tens of thousands of potentially malfunctioning EpiPens to the U.S. and other markets throughout the world but says it has…

Mylan is recalling more than 4 million bottles of cholesterol fighter atorvastatin because some of the tablets might be contaminated.

The FDA scolded a Singapore maker of eye washes and other consumer products for poor manufacturing processes.

A recent FDA warning letter issued to Chinese API maker Jinan Jinda Pharmaceutical Chemistry says the company's efforts to fix issues are still not enough.

An Indian drugmaker whose Mumbai plant got nailed by an FDA warning letter several years ago is again under the gun for making some of the same mistakes at a…

The FDA last month issued a warning letter to Pfizer for a sterile injectables plant in Kansas. Now the FDA has posted details of the inspection that led to…

Mylan is recalling lots of the Type 2 diabetes med Glipizide and the antidepressant Mirtazapine after stray tablets were discovered in bottles of the meds.

Placing a company on the FDA import alert list does not guarantee its products won't get into the U.S., as a recent warning letter shows.

The FDA said in a warning letter that an Indian API maker had not ensured that water it gets from a nearby river is sanitary before using it to make its…

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