Environmental Impact Review at CDER

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse reactions (side effects) in patients yo

FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar to its reference product Novolog (insulin aspart), to improve glycemic control in adults and children with diabetes mellitus.

August Egg Company of Hilmar, CA is recalling 1,700,000 dozen brown cage free and brown certified organic eggs, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and other

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October 26, 2025, Peterson Company of Auburn, WA is voluntarily recalling Twin Sisters Creamery brand item# 28855 Whatcom Blue and item# 29608 Farmhouse Cheese products which were made from raw milk because they may be contaminated with Shiga toxin-producing