New England Home Therapies Inc. Southborough, MA. 483 Issued 01/27/2016

FOR IMMEDIATE RELEASE – Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies is voluntarily recalling three lots (numbers 6133156, 6133194, 6133388) of Famotidine Injection, USP, 20 mg

Inotiv Inc. – 10/24/2025. Country: United States. Record Type: 483

FDA’s Drug Competition Action Plan (DCAP) encourages robust and timely market competition for generic drugs and helps bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.

Friendly’s Ice Cream is voluntarily recalling a limited quantity (324 cartons) of 48 fl. oz. Cookies & Cream ice cream because of undeclared soy and wheat. The recalled product was mistakenly packaged in Friendly’s Vanilla Bean ice cream cartons with a Cookies & Cream lid. People who have an allergy

This page outlines the deferral requests and advice letters issued by FDA to manufacturers of over-the-counter (OTC) topical antiseptic products. These products are categorized as either consumer or health care and they include rubs and washes.

The U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market.