États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
Showing 24 of 17,562 results
Food & Beverage
FDA Food
FDA FoodJalapeno Ranch, packed in 16 oz. glass jars, 6 jars per case, with UPC #199284564923.
Jaime's Foods ATX, LLC
FDA FoodClass I
Jalapeno Ranch, packed in 16 oz. glass jars, 6 jars per case, with UPC #199284564923.
Undeclared Egg Allergen
Sep 2, 2026Jaime's Foods ATX, LLC
Medical DeviceFDA Devices
FDA DevicesHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03
AVID Medical, Inc.
FDA DevicesClass II
Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Sep 2, 2026AVID Medical, Inc.
Food & BeverageFDA Food
FDA FoodBLACK AND WHITE GLUTINOUS RICE BALLS WITH BLACK SESAME FILLING NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000084
KHONG GUAN (HQ)
FDA FoodClass I
BLACK AND WHITE GLUTINOUS RICE BALLS WITH BLACK SESAME FILLING NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000084
Undeclared peanuts.
Sep 2, 2026KHONG GUAN (HQ)
Medical DeviceFDA Devices
FDA DevicesFUJIFILM Synapse PACS software v7.4.310; radiological image processing system
FUJIFILM Healthcare Americas Corporation
FDA DevicesClass II
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Software issue may cause the ruler measurement to be inaccurate.
Sep 2, 2026FUJIFILM Healthcare Americas Corporation
Food & BeverageFDA Food
FDA FoodByron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Byron White Formulas, Inc.
FDA FoodClass II
Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Label does not declare walnuts in English
Sep 2, 2026Byron White Formulas, Inc.
Food & BeverageFDA Food
FDA FoodOutshine Fruit Bars Strawberry, Pineapple, Grape, Tangerine. 24-Count 2.5 ounce, UPC 041548816678, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc.
FDA FoodClass II
Outshine Fruit Bars Strawberry, Pineapple, Grape, Tangerine. 24-Count 2.5 ounce, UPC 041548816678, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Foreign object: products may contain glass pieces
Sep 2, 2026Dreyer's Grand Ice Cream Inc.
Food & BeverageFDA Food
FDA FoodOutshine Fruit Bars Tangerine, 6-Count 2.5 ounce, with UPC 041548612041, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc.
FDA FoodClass II
Outshine Fruit Bars Tangerine, 6-Count 2.5 ounce, with UPC 041548612041, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Foreign object: products may contain glass pieces
Sep 2, 2026Dreyer's Grand Ice Cream Inc.
Medical DeviceFDA Devices
FDA DevicesMedline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
Medline Industries, LP
FDA DevicesClass II
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
Kits contain a potentially contaminated component which were recalled by the manufacturer
Sep 2, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesFresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC
FDA DevicesClass II
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
Sep 2, 2026Fresenius Medical Care Renal Therapies Group, LLC
Food & BeverageFDA Food
FDA FoodSura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #05410 retail package, UPC 085315054108 Item #05410.1 cardboard box (12 packages per case), UPC 085315054105 Product is Perishable Frozen or Refrigerated and made by Sun Noodle Hawaii 1933 Colburn Street, Honolulu, HI
H & U Inc. dba Sun Noodle
FDA FoodClass I
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #05410 retail package, UPC 085315054108 Item #05410.1 cardboard box (12 packages per case), UPC 085315054105 Product is Perishable Frozen or Refrigerated and made by Sun Noodle Hawaii 1933 Colburn Street, Honolulu, HI
Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.
Sep 2, 2026H & U Inc. dba Sun Noodle
PharmaceuticalFDA Drugs
FDA DrugsRamipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
Hikma Pharmaceuticals USA INC.
FDA DrugsClass II
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Sep 2, 2026Hikma Pharmaceuticals USA INC.
PharmaceuticalFDA Drugs
FDA DrugsLevothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
ACCORD HEALTHCARE, INC.
FDA DrugsClass II
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
Subpotent Drug
Sep 2, 2026ACCORD HEALTHCARE, INC.
PharmaceuticalFDA Drugs
FDA DrugsLevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.
ACCORD HEALTHCARE, INC.
FDA DrugsClass II
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.
Subpotent Drug
Sep 2, 2026ACCORD HEALTHCARE, INC.
PharmaceuticalFDA Drugs
FDA DrugsLevothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
ACCORD HEALTHCARE, INC.
FDA DrugsClass II
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Subpotent Drug
Sep 2, 2026ACCORD HEALTHCARE, INC.
PharmaceuticalFDA Drugs
FDA DrugsLevothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.
ACCORD HEALTHCARE, INC.
FDA DrugsClass II
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.
Subpotent Drug
Sep 2, 2026ACCORD HEALTHCARE, INC.
PharmaceuticalFDA Drugs
FDA DrugsClobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
Lupin Pharmaceuticals Inc.
FDA DrugsClass II
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
Failed content uniformity specifications.
Sep 2, 2026Lupin Pharmaceuticals Inc.
PharmaceuticalFDA Drugs
FDA DrugsLevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-449-17.
ACCORD HEALTHCARE, INC.
FDA DrugsClass II
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-449-17.
Subpotent Drug
Sep 2, 2026ACCORD HEALTHCARE, INC.
PharmaceuticalFDA Drugs
FDA DrugsActhar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
Mallinckrodt Hospital Products Inc.
FDA DrugsClass II
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
Presence of particulate matter: glass and stopper piece
Sep 2, 2026Mallinckrodt Hospital Products Inc.
PharmaceuticalFDA Drugs
FDA DrugsLevothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17.
ACCORD HEALTHCARE, INC.
FDA DrugsClass II
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17.
Subpotent Drug
Sep 2, 2026ACCORD HEALTHCARE, INC.
PharmaceuticalFDA Drugs
FDA DrugsZicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
Church & Dwight Co., Inc.
FDA DrugsClass II
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Sep 2, 2026Church & Dwight Co., Inc.
PharmaceuticalFDA Drugs
FDA DrugsLevothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
ACCORD HEALTHCARE, INC.
FDA DrugsClass II
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Subpotent Drug
Sep 2, 2026ACCORD HEALTHCARE, INC.
Medical DeviceFDA Devices
FDA DevicesAmerican Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
American Contract Systems Inc
FDA DevicesClass II
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Sep 2, 2026American Contract Systems Inc
PharmaceuticalFDA Drugs
FDA DrugsTyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
Fresenius Kabi USA, LLC
FDA DrugsClass I
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Sep 2, 2026Fresenius Kabi USA, LLC
PharmaceuticalFDA Drugs
FDA DrugsPaxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Apotex Corp.
FDA DrugsClass II
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Sep 2, 2026Apotex Corp.