FDA is announcing today it has placed Elevidys and certain Sarepta investigational gene therapy clinical trials for limb girdle muscular dystrophy on clinical hold due to new safety concerns that the study participants are or would be...
CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.
Eligibility requirements for a regenerative medicine advanced therapy (RMAT) designation. Information on when and where to submit the request is also provided.
The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.
Are recalling Frozen ‘Deep Sprouted Mat(Moth) 16 oz. and Deep Sprouted Moong 16oz. because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infection in young children,...
For active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MNEXSPIKE is approved for use in individuals who have been previously vaccinated with any...
The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.
Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials...
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued a voluntary recall related to certain Alaris™ and BD Alaris™ Pump Modules that may have been serviced with previously recalled...
World Market is recalling EMEK SPREAD PISTACHIO CACAO CREAM WITH KADAYIF, 9.7oz, Best Before: April 01, 2027, Batch Number: 250401 due to a potential contamination of Salmonella. Salmonella is an organism which can cause serious and...
Danone U.S. is voluntarily recalling YoCrunch® products sold at retail stores nationwide due to the potential presence of plastic pieces in the dome topper. If consumed, the plastic pieces could potentially cause a choking response. The...
July 14, 2025, Jalux Americas, Inc.(dba J.sweets) of El Segundo, CA is recalling 32 units of L’espoir Brand L’espoir cookies and 28 units of L’espoir Brand Drycapot cookies, because they may contain the following undeclared allergens: in...
Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts...
On May 22, 2025, the committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2025-2026 Formula for COVID-19 vaccines.
Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels consistent with good manufacturing...
Hartford Bakery, Inc. is voluntarily recalling six lots of its “Lewis Bake Shop Artisan Style 1/2 Loaf” as this product may contain undeclared hazelnuts. People with a nut allergy or severe sensitivity to hazelnuts run the risk of...
Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S....
LLK TRADING INC. of Linden, NJ, is recalling its 200g packages of “Needle Mushrooms” because it has the potential to be contaminated with Listeria monocytogenes
Hartford Bakery, Inc. is voluntarily recalling six lots of its “Lewis Bake Shop Artisan Style 1/2 Loaf” as this product may contain undeclared hazelnuts. People with a nut allergy or severe sensitivity to hazelnuts run the risk of...
The U.S. Food and Drug Administration encourages industry leaders involved in manufacturing and distribution of infant formula, baby foods, and foods intended for children to streamline and enhance product recall communications.
Mondelēz Global LLC announced today a voluntary recall of four carton sizes of RITZ Peanut Butter Cracker Sandwiches (8-pack, 20-pack, and 40pack cartons of RITZ Peanut Butter Cracker Sandwiches, as well as the 20-pack RITZ Filled...
Natureen International Inc. of Walnut, CA is recalling 244 bags of Wei-Chuan Dried Black Fungus Slice (2.5oz / bag), because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal...
Springfield, Ohio (July 8, 2025)- Sheehan Brothers Vending is recalling its Cheeseburgers, Spicy Chicken Sandwich, Italian Mini Subs, Pepperoni Pizza Sub, Chili Cheese Coney and BBQ Riblet w/coleslaw due to an undeclared Sesame allergen....
CHS Inc. is voluntarily recalling seven tons of Payback® Champion Lamb Text B30 with Power Booster due to potentially elevated levels of copper. Symptoms of copper toxicity in sheep include lethargy and anemia, grinding of teeth, thirst,...
Nirwana Foods of NJ is recalling its 28-ounce pouches Golden Raisin with lot number (24/351-2410) because they may contain undeclared sulfites. People who have allergies to sulfites run the risk of serious or life-threatening allergic...