Hazard
20 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 20 unapproved product recalls we have scored against our rubric, 5 (25%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (35%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unapproved product recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Hard Steel Capsules contain undeclared acetaminophen and sildenafil and were marketed without FDA approval. All 729 units distributed nationwide and internationally are included in the recall.
Farmalac 0-12 Low lactose powdered infant formula is being recalled because the manufacturer did not submit required premarket notification to the FDA. The product has not been evaluated against U.S. food safety and nutritional standards.
Sammy's Milk goat formula is recalled for marketing it as safe for infants. The unapproved product does not comply with FDA infant formula manufacturing requirements.
Able Groupe Inc is recalling HiPP Dutch Stage 1 Combiotic Infant Milk Formula because it was not approved by the FDA and may contain insufficient iron for vulnerable infants, particularly those born prematurely or with low birth weight.
Able Groupe Inc is recalling HiPP UK Stage 1 Combiotic First Infant Milk Formula because required pre-market FDA notifications were not submitted. Some products contain insufficient iron and lack mandatory labeling.
Able Groupe Inc is recalling HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English-language labeling as required by federal regulations.
Able Groupe Inc is recalling HiPP AR Germany Anti-Reflux Milk Formula because required pre-market FDA notifications were not submitted and products lack mandatory English labeling required by federal regulations.
Zero Xtreme USA is recalling 16 bottles of Zero Xtreme Dietary Supplement capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.
3CS Organics LLC is recalling Holle goat milk infant formula products that are not FDA approved and lack English labeling.
3CS Organics is recalling HIPP Organic infant milk products because they are not FDA approved and lack full English labeling.
3CS Organics LLC is recalling Topfer Lactana Bio infant and follow-up formula because the product is not FDA approved and lacks complete English labeling.
3CS Organics LLC is recalling HIPP Bio Combiotik infant formula products because they are not FDA approved and not all products are labeled in English.
3CS Organics LLC is recalling HIPP infant formula products because they are not FDA approved and lack complete English labeling.
3CS Organics LLC is recalling HOLLE organic infant formula products because they are not FDA approved and lack English labeling.
Blue Square Market, Inc. is recalling LiDa DAIDAIHUA capsules nationwide because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA or ANDA.
Instradent USA is recalling 13 units of Neodent Titamax WS Cortical Implants because the product is not approved for use in the US.
Nature's Universe is recalling ThinoGenics dietary supplements because they contain undeclared sibutramine and were marketed without FDA approval.
Super ARTHGOLD dietary supplement is being recalled because it contains undeclared prescription drugs and was marketed without FDA approval.
B @ B Trade Inc. is recalling Slim Fortune capsules because they contain undeclared sibutramine and were marketed without FDA approval.
B @ B Trade Inc. is recalling Lidiy capsules because the dietary supplement was marketed without FDA approval and contains undeclared sibutramine.