FDA Recalls in 2025
2,242 recalls found
September 2025
NEUHAUS brand ORIGINAL BELGIAN CHOCOLATE; POPPING MILK CHOCOLATES WITH COOKIES; 4.23 oz - 120g; (EN)Chocolates - INGREDIENTS: milk chocolate (sugar, whole milk powder, cocoa mass, cocoa butter, emulsifier: soy lecithin, flavour), sugar, sunflower oil, whole milk powder, cocoa butter, skimmed milk powder, carmelised sugar, cocoa mass, glucose syrup, emulsifier: soy lecithin, spices, lactose, flavours, acidity regululator: malic acid; carbon dioxide. May contain traces of eggs, sesame, groundnuts
Product contains undeclared wheat.
Honey Balsamic dressing, 3.4 ounce plastic pouch, Best by date and Lot number appear directly on pouch.
Product contains undeclared Soy and Sesame
Top Secret Nutrition extra strength uric control fast acting multi-pronged uric acid control 30 veggie caps DIETARY SUPPLEMENT UPC 8 11226 02158 4 Distributed by: TOP SECRET NUTRITION, LLC 6015-B Unity Dr. Norcross, GA 30052
Unapproved Drug Claims.
Brand name: BulkSupplements.com Generic name: Inositol. Dosage: 1 gram. Form: Powder. Route of administration: Oral. Packaging is flexible plastic. Net Wt.: 8.8 oz (250 grams), 1.1 lbs (500 grams), 2.2 lbs (1 kilogram). UPC: 849720004147, 849720004154, 849720004161 Firm Name/Address: Hard Eight Nutrition LLC dBa BulkSupplements.com 640 W Lake Mead Pkwy Henderson, NV 89015, USA.
Finished product possibly contaminated with pathogenic Staphylococcus aureus.
Cream Caramels, Milk, Item ID: 2210L. Packed On (YYMMDD): 25-06-16. 6.26 lb. Box. Abdallah Candies
Undeclared allergen (peanut, pecan).
Bake-a-holic Pecan Bars Cheesecake Royale Pecan Bars
Review of Label determined allergen was listed as unsalted butter/ heavy cream. In one instance of identified label, there was no milk or dairy listed listed in Contains statement. Further review of label revealed "soy" had been removed.
HI-TECH PHARMACEUTICALS PINE BARK SUPPORTS HEART HEALTH & CIRCULATION SUPPORTS CARDIOVASCULAR HEALTH FIGHTS OXIDATIVE STRESS 60 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02446 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Spanish Club Ciabatta; Keep Refrigerated, NET WT: 10.5 OZ, UPC# 6 82906 90933 7 Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340
undeclared allergen (Wheat and Milk) on ready to eat sandwiches.
FORMUTECH NUTRITION FLEXIBLE JOINT FORMULA WITH CISSUS QUADRANGULARIS SUPPORTS TENDONS & MUSSCLES PROMOTES HEALTH CARTILAGE LUBRICATES JOINTS 240 Capsules UPC 7 97573 90884 1 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims.
HI-TECH PHARMACEUTICALS QUERCETIN STRENGTHENS IMMUNE SYSTEM SUPPORTS RESPIRATORY HEALTH SUPPORTS CARDIOVASCULAR HEALTH 120 TABLETS DIETARY SUPPLEMENT UPC 8 11836 02491 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
HI-TECH PHARMACEUTICALS L-GLUTAMINE ULTRA PURE POWDER HPLC VERIFIED 99.5% PURITY CELL VOLUMIZATION MUSCLE SIZE POWER RECOVERY ENERGY STRENGTH LACTIC ACIDE ELIMINATION LEAN MUSCLE 500 GRAMS NET WT. (17.630OZ) DIETARY SUPPLEMENT UPC 8 11836 02362 6 HI-TECH PHARMECEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims.
CAMPSITE LENTEJAS Hearty lentil soup with a tomato and cilantro base that takes no time to rehydrate. NET WT 4.0 OZ (115G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDER, CORN STARCH, MALTODEXTRIN, HYDROLYZED CORN PROTEIN, GARLIC POWDER, TURMERIC (COLOR), SPICES, CARROT JUICE CONCENTRATE, CALCIUM SILICATE (ANTICAKING AGENT), CARAMEL COLOR, NATURAL FLAVORS, DISODIUM INOSINATE, DISODIUM GUANYLATE, CITRIC ACID) ***
Undeclared Yellow #5 and Yellow #6.
Sand Bar; Great American; and First Street branded Frozen raw shrimp; 2 pound plastic bag; UPC#: 011110641182; 829944010612; 041512179471; 829944010698; 8299440106636
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
HI-TECH PHARMACEUTICALS ADDEREX XR STRONGEST FOCUSING AID WITHOUT A PRESECRIPTION! HELPS ADULTS MAINTAIN CONCENTRATION & IMPROVE PRODUCTIVITY! 30 TABLETS UPC 8 11836 02691 7 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Cucumber Peeled Sliced KBS 2/5lb, Cardboard Boxes
Product contaminated with Salmonella
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT PEACH MANGO NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPLEMENT UPC 6 38302 40906 3 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
IFN iFORCE NUTRITION JOINT HELP HEALTHY JOINTS & LIGAMENTS DIETARY SUPPLEMENT 120 CAPSULES UPC 8 54503 00226 5 Manufactured By: iForce Nutrition 6015B Unity Drive Norcross, GA 30071
Unapproved Drug Claims.
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT WATERMELON NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPLEMENT UPC 6 38302 40905 6 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Cucumber Sliced 8oz 8ct/4#AV, Cardboard Boxes
Product contaminated with Salmonella
Cucumber Sliced PLD ¿ KBS 2/10lb, Cardboard Boxes
Product contaminated with Salmonella
PRIMENUTRITION PHYTOFORM FRUITS & GREENS FORMULA 30 SERVINGS DETOXIFICATION IMPROVE ENERGY SWEETENED WITH MONK FRUIT KIWI-STRAWBERRY NATURALLY & ARTIFICIALLY FLAVORED NET WT 13.75 OZ (390g) DIETARY SUPPLEMENT UPC 6 89466 70619 2 Manufactured by: Prime Nutrition 6015-b Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
LGSCIENCES BATTLE HARDENER PLATINUM SERIES COMPLETE 6 WEEK CYCLE WITH PCT LEGAL GEAR DIETARY SUPPLEMENT 17-PROANDRO pBOLD FORM-XT UPC 7 44890 94151 6 MADE FOR LG SCIENCES 6015-B UNITY DR. NORCROXX, GA 30071
Unapproved Drug Claims.
Vanilla G. Nutt Ice Cream (pint, quart, or half gallon)
May contained undeclared almond
Vegetable Tray Cucumbers 3/2lb, Cardboard boxes
Product contaminated with Salmonella
Endico brand PEAS & CARROTS; NET WT. 2.5 lbs (40 oz.) (1134 g); KEEP FROZEN UNTIL READY TO USE; Dist. by Endico Potatoes Inc; PRODUCT OF EGYPT; To prepare: Place contents in boiling water. Cook until tender. Season to taste and serve.; Cook to 165 F For Quality And Food Safety; INGREDIENTS: Peas and Carrots
Product may be contaminated with Listeria monocytogenes.
HI-TECH PHARMACEUTICALS JOINT-RX DIETARY SUPPLEMENT 600mc Helps Rebuild Cartilage & Ease Pain Revolutionary Joint Support System 90CT UPC 8 57084 00035 4 Hi-Tech Pharmaceuticals, Inc. 6015-B Unity Dr Norcross, GA 30071
Unapproved Drug Claims.
HI-TECH PHARMACEUTICALS SLIMAGLUTIDE REVOLUTIONARY WEIGHT LOSS AID WITH GLUCAGON-LIKE PEPTIDE-1 (GLP-1) RECEPTOR AGONIST AND SECRETAGOGUES NOVEL GIP (GLUCOSE-DEPENDENT ISNULINOTROPIC POLYPEPTIDE) RECEPTOR AGONIST 180 TABLETS DIETARY SUPPLEMENT
Unapproved Drug Claims and Misbranded.
Goldband Snapper Pristipomoides spp Fillets Skin-on Frozen, size 8-10oz, , item #991900011, individually Vacuum Package (IVP) portions in a plain white cardboard box, net wt. 10 lbs. per box. Product is wild caught, product of Indonesia, distributed by E&E Foods, Renton, WA.
Goldband Snapper is recalled because testing confirmed fish is Sharptooth Snapper.
Chili Crunch Market Mezze; Keep Refrigerated, NET WT: 14.5 OZ, UPC# Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340
undeclared allergen (Wheat) on ready to eat sandwiches.
Piccolo Pranzo Box; Keep Refrigerated, NET WT: 14.5 OZ, UPC# Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340
undeclared allergen (Wheat and Milk) on ready to eat sandwiches.
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 70242-109-01
Defective Container: broken or leaking bottles.
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-6186-67, Carton NDC# 0781-6186-67
Temperature Abuse
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
Presence of a foreign substance.
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
Presence of a foreign substance.
Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01
cGMP violations
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808, NDC 84803-110-01 (15 mL Velvet Screen), UPC 9355909005757.
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1377-1 (vial), NDC 70710-1377-2 (carton).
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 9355909005924, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808.
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1133-1
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.