Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Micro Therapeutics, Inc.
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Medical Devices·8 affected·Jun 30, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day...
Ophthalmic Drugs·9 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Steri...
Ophthalmic Drugs·1 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Heal...
Drugs·67 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Ste...
Oral Drugs·23 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
Topical Drugs·40 affected·Jun 29, 2022
High RiskFDA
Teva Pharmaceuticals Usa Inc
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis ...
Topical Drugs·12,354 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservati...
Oral Drugs·1 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 043...
Drugs·113 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexi...
Drugs·0 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
Drugs·16 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144...
Topical Drugs·6 affected·Jun 29, 2022
Medium RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc...
Oral Drugs·168,936 affected·Jun 29, 2022
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot n...
Oral Drugs·72,288 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0...
Ophthalmic Drugs·12 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.
Drugs·45 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Rel...
Ophthalmic Drugs·47 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Al...
Ophthalmic Drugs·12 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
Drugs·131 affected·Jun 29, 2022
RecallFDA
Eco Lips, Inc
Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, ...
Drugs·35,313 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
Topical Drugs·1 affected·Jun 29, 2022
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot...
Oral Drugs·0 affected·Jun 29, 2022
RecallFDA
Eco Lips, Inc
Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active I...
Drugs·15,313 affected·Jun 29, 2022
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by:...
Oral Drugs·36 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.
Drugs·10 affected·Jun 29, 2022
High RiskFDA
Trinity Sterile, Inc.
Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
Medical Devices·5 affected·Jun 29, 2022
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant P...
Medical Implants·872 affected·Jun 29, 2022
High RiskFDA
Trinity Sterile, Inc.
Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF
Medical Devices·4,169 affected·Jun 29, 2022
High RiskFDA
Orthopediatrics Corp
Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Medical Devices·640 affected·Jun 29, 2022
High RiskFDA
Trinity Sterile, Inc.
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
Medical Devices·2,512 affected·Jun 29, 2022
RecallFDA
Hy-vee, Inc. Dba Hy-vee Fresh Commissary
HyVee Oven Baked Beans in 16 OZ plastic containers (UPC 0075450500640, 12 retail units per case)
Food·194 affected·Jun 28, 2022
High RiskFDA
Vi-jon, Llc
Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3 21130-780...
Topical Drugs·3,421,032 affected·Jun 28, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin...
Diagnostic Devices·1,614 affected·Jun 28, 2022
CriticalFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Cardiac Devices·19,616 affected·Jun 28, 2022
RecallFDA
Aniara Diagnostica Llc
BIOPHEN UFH Control Plasma
Medical Devices·13 affected·Jun 28, 2022
CriticalFDA
Fuchs North America, Inc.
Za'atar Seasoning, Cust Part # Lot No. 252491, NET WT 50 lbs bag in a box. One bag per box, GT 74862, Lot code: 252491.
Food·700 affected·Jun 27, 2022
CriticalFDA
Loud Muscle Science
Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
Oral Drugs·500 affected·Jun 27, 2022
CriticalFDA
Loud Muscle Science
Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Oral Drugs·5,421 affected·Jun 27, 2022
CriticalFDA
Loud Muscle Science
Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
Oral Drugs·1,000 affected·Jun 27, 2022
High RiskFDA
Loud Muscle Science
Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.
Oral Drugs·1,500 affected·Jun 27, 2022
High RiskFDA
Sun Pharmaceutical Industries Inc
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury...
Oral Drugs·9,552 affected·Jun 27, 2022
CriticalFDA
Valor Compounding Pharmacy, Inc Dba Valor Compounding Pharmacy
Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
Topical Drugs·5 affected·Jun 27, 2022
High RiskFDA
Loud Muscle Science
Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Oral Drugs·2,495 affected·Jun 27, 2022
High RiskFDA
Loud Muscle Science
Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
Oral Drugs·1,500 affected·Jun 27, 2022
High RiskFDA
Icu Medical, Inc.
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,Che...
Medical Devices·454,635 affected·Jun 27, 2022
High RiskFDA
Smith & Nephew, Inc.
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Prod...
Medical Devices·31 affected·Jun 27, 2022
CriticalFDA
Hamilton Medical Ag
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Respiratory Devices·358 affected·Jun 27, 2022
High RiskFDA
Icu Medical, Inc.
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20...
Medical Devices·358,975 affected·Jun 27, 2022