305 recalls tagged with “federal law violation”.
Baker's Authority LLC recalls 78 units of Three Seed Mix, 5 lb bags, distributed to multiple states. The recall follows labeling errors that fail to list sesame as an ingredient. Consumers who purchased this product should not consume it and should email Baker's Authority LLC for refund or replacement information.
Lannett Company, Inc. recalls 8,544 bottles of Lisdexamfetamine Dimesylate 40 mg capsules distributed nationwide. A labeling mix-up may have placed 30 mg and 40 mg strengths in mislabeled bottles. Healthcare providers and patients should stop use and contact the company for guidance.
Schiller, AG recalls 266 Argus PB-3000 vital sign monitors nationwide in the United States. The devices may display an error message during blood pressure measurements when the initial inflation pressure is set high. Authorities urge users to stop using the device and follow manufacturer instructions.
La Ligne recalls Enfant Bonne Nuit children’s pajamas after a burn hazard was identified. The recall covers La Ligne by La Ligne Enfant Bonne Nuit two-piece sets sold in various colors. Consumers should stop using the pajamas and pursue a full refund or store credit.
Deale International recalls Altafit AF28 smartwatches sold by HSN after reports of overheating charging pads. The recall cites a risk of serious burn injury and fire. Consumers should stop charging the watch immediately and contact Deale International for a free replacement.
Prime Nutrition PhytoForm Fruits & Greens Formula recall affects 85,950 units distributed nationwide. Hi-Tech Pharmaceuticals Inc. will handle refunds or replacements. The product carries unapproved drug claims and is misbranded. Consumers who purchased this product should not consume it and should contact the company for refund or replacement information.
Hi-Tech Pharmaceuticals recalled 85,950 units of Fish Oil Heart and Brain Health EPA/DHA Omega-3 soft gels distributed nationwide after regulators flagged unapproved drug claims. The FDA enforcement notice identifies unapproved health claims associated with the product. Consumers who bought this product should stop using it and contact Hi-Tech Pharmaceuticals for refunds or replacements.
Hi-Tech Pharmaceuticals recalled 85,950 units of iFORCE Joint Help Healthy Joints & Ligaments Dietary Supplement after regulators flagged unapproved drug claims. The product was distributed to 50 states. Consumers should stop using the product and contact Hi-Tech Pharmaceuticals for refund or replacement.
Hi-Tech Pharmaceuticals recalled 85,950 units of Adderex XR Strongest Focusing Aid sold nationwide after regulators found unapproved drug claims and misbranding. The product claims to boost concentration without a prescription. Consumers who bought the product should not use it and should contact the company for a refund or replacement.
Hi-Tech Pharmaceuticals recalled 85,950 units of L-Glutamine Ultra Pure Powder distributed to multiple retailers after FDA enforcement over unapproved drug claims. The product’s labeling asserts drug-like benefits without FDA approval. Consumers should not consume the product and should contact Hi-Tech Pharmaceuticals for refund or replacement by mail to 6015-B Unity Drive, Norcross, GA 30071.
Hi-Tech Pharmaceuticals recalled 85,950 units of PrimeNutrition PhytoForm Fruits & Greens Formula dietary supplement on Aug. 6, 2025. The product was manufactured by Prime Nutrition and distributed nationwide. The recall cites unapproved drug claims and misbranding. Consumers should not use the product and should contact Hi-Tech Pharmaceuticals for refund or replacement.
Enoxaparin Sodium Injection recall active as of 2025. Cardinal Health and Sandoz Inc. distributed the product in Kansas. Bags labeled 80 mg/0.8 mL contained 30 mg/0.3 mL doses. Health authorities urge immediate stop-use and guidance from providers.
B. Braun Medical Inc. recalls 74,088 Lactated Ringers Injection USP containers nationwide over sterility concerns. The recall cites potential fluid leakage at weld sites and lack of assurance of sterility. Healthcare providers and patients should stop use and seek guidance from their supplier or provider immediately.
AVID Medical recalled 57 JACK421-04 ENT PACK convenience kits nationwide in Florida. The open header bag seals could compromise sterility. Consumers should stop using the device and follow manufacturer instructions for recall resolution.
DFA Dairy Brands recalls 54 cases (324 containers) of a Friendly's branded frozen dessert due to undeclared wheat and soy. The recall covers product distributed in MD, VA, and PA. Consumers should avoid consumption and contact DFA Dairy Brands for refunds or replacements.
Tegu recalled two Magnetic Floating Stackers sold at multiple retailers. Models STA-BGY-801T and STA-BTP-806T are affected. The magnets can detach and be ingested, posing a serious injury or death risk. Parents should stop using the toys immediately and contact Tegu for a free replacement.
Eight modular LinkSymphoKnee TiNbN tibial components are under recall after production with two uncoated security screws. Waldemar Link GmbH & Co. KG disclosed the issue. The devices were distributed worldwide, including CO, IN, NJ and TX in the United States, plus Germany and Italy. Consumers should stop using the device immediately and follow manufacturer instructions.
Amazon recalled Amazon Basics Premium Foam Eurotop Mattresses sold on Amazon. The nine-inch mattresses in twin, full, queen and king sizes were manufactured from 12/22/2022 through 05/16/2024 and violate the federal flammability standard, posing a fire hazard. Stop using the recalled mattress and contact Amazon for a full refund.
Fortress Introducer Sheath System recalled 2,500 units linked to label mispackaging. The devices were distributed worldwide, including 15 U.S. states and numerous international markets. The incorrect pouch label lists the 4F version reference and unique device identifier instead of the packaged 6F version. Healthcare providers must stop use and follow manufacturer recall instructions.
A recall is active for Sucralfate Tablets, USP 1 gram distributed by American Health Packaging. The firm filed for Chapter 11 in September 2024, triggering CGMP deviations and questions about product identity, strength, quality and purity. The recall affects 26,992 blister packs distributed nationwide. Stop using the product and contact Amerisource Health Services or your clinician for guidance.