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
www.fda.gov →Official Site
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How to report to FDA →68,659 recalls
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2...
Medical Devices204 affectedJul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCU...
Cardiac Devices31,506 affectedJul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; ...
Cardiac Devices6,617 affectedJul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE P...
Medical Devices1,233 affectedJul 14, 2025
High RiskFDA
American Contract Systems Inc
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCO...
Medical Devices1,094 affectedJul 14, 2025
High RiskFDA
Danone Us Llc
YoCrunch Low Fat Yogurt with Toppers, Strawberry with milk chocolate M&Ms minis candies, Packaged in the following size containers: 1. ...
Dairy2,492,073 affectedJul 11, 2025
High RiskFDA
Danone Us Llc
YoCrunch Lowfat Yogurt with Toppers, Vanilla with milk chocolate M&Ms, Packaged in the following size containers: 1. Single Serve Cup ...
Dairy2,492,073 affectedJul 11, 2025
High RiskFDA
Danone Us Llc
YoCrunch Low Fat Yogurt with Toppers, Vanilla with Snickers pieces, Packaged in the following size containers: 1. Single Serve Cup, 6 ...
Dairy2,492,073 affectedJul 11, 2025
High RiskFDA
Danone Us Llc
YoCrunch Low Fat Yogurt with Toppers, Vanilla with Chocolate Chip Cookie Dough pieces, Multipack containing 4-4 oz. (113g) cups. UPC 466...
Dairy2,492,073 affectedJul 11, 2025
High RiskFDA
Danone Us Llc
YoCrunch Low Fat Yogurt with Toppers, Vanilla with Twix bar pieces, Packaged in the following size containers: 1. Single Serve Cup, 6 ...
Dairy2,492,073 affectedJul 11, 2025
High RiskFDA
Danone Us Llc
YoCrunch Lowfat Yogurt with Toppers. Two-product package. Contains 8-6oz (170g) cups of Strawberry Yogurt with milk chocolate M&Ms piec...
Dairy2,492,073 affectedJul 11, 2025
High RiskFDA
Danone Us Llc
YoCrunch Lowfat Yogurt with Toppers Two-product package. Contains 8-6oz (170g) cups of Strawberry Yogurt with Granola pieces (Cup UPC 46...
Dairy2,492,073 affectedJul 11, 2025
High RiskFDA
Danone Us Llc
YoCrunch Lowfat Yogurt with Toppers. Two-product package. Contains 8-6oz (170g) cups of Vanilla Yogurt with Snickers pieces (cup UPC 46...
Dairy2,492,073 affectedJul 11, 2025
High RiskFDA
Danone Us Llc
YoCrunch Low Fat Yogurt with Toppers, Strawberry with Granola pieces, Single Serve Cup, 6 oz. (170g) UPC 46675-00010. Keep Refrigerated...
Dairy2,492,073 affectedJul 11, 2025
High RiskFDA
Nostrum Laboratories, Inc.
Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-0003-01, and b) 500-count bottles, NDC 29033-0003-05), Rx Only...
Oral Drugs60,608 affectedJul 11, 2025
High RiskFDA
Remel, Inc
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
Medical Devices1,552 affectedJul 11, 2025
CriticalFDA
Icu Medical, Inc.
Plum Duo Infusion System, List Number: 400020401
Medical Devices4,677 affectedJul 11, 2025
CriticalFDA
Flexicare Medical (dongguan) Ltd.
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), ...
Medical Devices0 affectedJul 11, 2025
CriticalFDA
Flexicare Medical (dongguan) Ltd.
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
Medical Devices0 affectedJul 11, 2025
CriticalFDA
Flexicare Medical (dongguan) Ltd.
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
Medical Devices0 affectedJul 11, 2025
CriticalFDA
Flexicare Medical (dongguan) Ltd.
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Medical Devices0 affectedJul 11, 2025
High RiskFDA
Remel, Inc
Blood/MacConkey Biplate 100/PK, Product Number R02049
Medical Devices611 affectedJul 11, 2025
High RiskFDA
Remel, Inc
Strep Selective II Agar, Product Number R01859
Medical Devices371 affectedJul 11, 2025
CriticalFDA
Jalux America Inc
Drycapot cookie, net weight: 1.15 oz UPC#: 4 942737 210191
Bakery & Grains28 affectedJul 10, 2025
CriticalFDA
Jalux America Inc
Lespoir cookie, net weight: 1.41 oz. UPC# 4 942737 200147
Bakery & Grains32 affectedJul 10, 2025
High RiskFDA
A.p. Deauville, Llc
Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder Fresh Scent, 1.8 oz./53 mL, A.P Deauville, LLC, PA 18040, ND...
Drugs21,265 affectedJul 10, 2025
High RiskFDA
Pfizer Inc.
Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., Ne...
Injectable Drugs50,855 affectedJul 10, 2025
High RiskFDA
A.p. Deauville, Llc
Beauty & Skincare Power Stick original nourishing invisible protection roll-on Antiperspirant/Deodorant Spring Fresh, 1.8 oz./53 mL, A.P...
Drugs22,482 affectedJul 10, 2025
High RiskFDA
Pfizer Inc.
Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units per 4 mL, 4ml-vial, Rx Only, Distributed by Pfizer Inc., Ne...
Injectable Drugs19,279 affectedJul 10, 2025
High RiskFDA
A.p. Deauville, Llc
Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant/Deodorant, 1.8 oz./ 53 mL, A.P Deauville,...
Drugs23,467 affectedJul 10, 2025
CriticalFDA
Mo-vis Bvba
IDM-MICRO-R. Electrical wheelchair component.
Medical Devices15 affectedJul 10, 2025
RecallFDA
Carefusion 303, Inc.
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PY...
Medical Devices6,076 affectedJul 10, 2025
High RiskFDA
Biofire Defense
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use wi...
Diagnostic Devices130 affectedJul 10, 2025
CriticalFDA
Mo-vis Bvba
Micro Joystick R-net. Electrical wheelchair component.
Medical Devices3 affectedJul 10, 2025
RecallFDA
Imprimis Njof, Llc
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Im...
Ophthalmic Drugs2,890 affectedJul 9, 2025
High RiskFDA
Boothwyn Pharmacy Llc
Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Injectable Drugs186 affectedJul 9, 2025
High RiskFDA
Ascend Laboratories, Llc
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distribut...
Oral Drugs0 affectedJul 9, 2025
RecallFDA
Boothwyn Pharmacy Llc
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Drugs8 affectedJul 9, 2025
High RiskFDA
Imprimis Njof, Llc
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgew...
Drugs6,880 affectedJul 9, 2025
High RiskFDA
Boothwyn Pharmacy Llc
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Injectable Drugs642 affectedJul 9, 2025
High RiskFDA
Strides Pharma, Inc.
Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, India; Distributed by: Stri...
Oral Drugs6,672 affectedJul 9, 2025
High RiskFDA
Ascend Laboratories, Llc
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distribute...
Oral Drugs0 affectedJul 9, 2025
High RiskFDA
Boothwyn Pharmacy Llc
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Injectable Drugs648 affectedJul 9, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Produc...
Medical Devices18 affectedJul 9, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Produc...
Medical Devices40 affectedJul 9, 2025
CriticalFDA
Ambu Inc.
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Merc...
Medical Devices87,156 affectedJul 9, 2025
CriticalFDA
B Braun Medical Inc
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Medical Devices34,825 affectedJul 9, 2025
High RiskFDA
Mondelez Global Llc
Ritz Peanut Butter Cracker Sandwiches, Net Wt. 11.4 oz, 8 count (8x1.38 oz 6 pack of cracker sandwiches inside carton. 14X8-Case: 14 - 11...
Dairy37,985 affectedJul 8, 2025