Recalls and safety alerts from the FDA, newest first.
Products contain undeclared soy, specifically soy lecithin. — Prospector Popcorn, LLC · Class II · Ongoing
Foreign object (stainless steel dust/flakes or shreds of plastic) — Dakota Honey Company · Class II · Ongoing
Contains undeclared FD&C Yellow 6 — Raja Foods and Vegetables Inc. · Class II · Ongoing
Undeclared allergen ingredient (fish) — Ocinet, Inc. · Class II · Ongoing
Foreign object (stainless steel dust/flakes or shreds of plastic) — Dakota Honey Company · Class II · Ongoing
Incorrect Product Formulation: product did not contain insulin as listed in the label. — Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles · Class II · Ongoing · 1 bag
Lack of assurance of Sterility: potential product contamination — CareFusion 213, LLC · Class II · Ongoing
Lack of assurance of Sterility: potential product contamination — CareFusion 213, LLC · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. — Ajanta Pharma Ltd. · Class II · Ongoing · 312,894 packs
Chemical contamination; presence of lead and lithium above specification — Acella Pharmaceuticals, LLC · Class II · Ongoing · 6,336 bottles
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test — JB Chemicals and Pharmaceuticals Ltd · Class II · Ongoing · 675 bottles
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. — Ajanta Pharma Ltd. · Class II · Ongoing
Subpotent drug — Unichem Pharmaceuticals USA Inc. · Class III · Ongoing
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit — Breckenridge Pharmaceutical, Inc. · Class II · Ongoing
Presence of Particulate Matter. — B BRAUN MEDICAL INC · Class I · Ongoing
Lack of Assurance of Sterility: Potential leaks from perforations in bags. — Fresenius Medical Care Holdings, Inc. · Class II · Ongoing
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. — Teva Pharmaceuticals USA, Inc · Class II · Ongoing
Lack of Assurance of Sterility: Potential leaks from perforations in bags. — Fresenius Medical Care Holdings, Inc. · Class II · Ongoing
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. — Ajanta Pharma Ltd. · Class II · Ongoing
Undeclared Yellow #5 — Silver Moon LP dba Loard's Ice Cream · Class II · Ongoing
Undeclared Milk, Soy, Red #40. — Silver Moon LP dba Loard's Ice Cream · Class II · Ongoing
Potential contamination with Salmonella. — California Dairies Inc. · Class I · Ongoing
Multi-state outbreak of E. coli O157:H7. — Raw Farm LLC · Class I · Ongoing
Package integrity compromised. — Horizon Organic Dairy, LLC · Class II · Completed