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
Beta Labs
RED VIPERS, ADVANCED FOCUS AND CONCENTRATION, HEIGHTENED ENERGY LEVELS, 75mg EPHEDRA, Manufactured for: Beta Labs, LTD, Newark, DE 197...
Food743 affectedJun 20, 2013
CriticalFDA
Taylor Farms New Jersey, Nj
Wawa Black Forest Ham and Cheese on a Pretzel Roll with swiss cheese and country dijon honey mustard. Net Wt. 8.7 oz (247g). Distribute...
Dairy520 affectedJun 20, 2013
High RiskFDA
Gilead Sciences, Inc.
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas P...
Injectable Drugs478,352 affectedJun 20, 2013
High RiskFDA
Haemonetics Corporation
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Medical Devices1,590 affectedJun 20, 2013
RecallFDA
Technidata S.a.
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Info...
Medical Devices1 affectedJun 20, 2013
High RiskFDA
Garden-fresh Foods, Inc.
LID: Archer Fames, Smoked Salmon dip, NET WT 11 OZ (312g). TUB: Archer Farms, Bacon Parmesan dip, NET WT 11 OZ (312g). UPC: 0 85239 99...
Seafood126 affectedJun 19, 2013
High RiskFDA
Astellas Pharma Us Inc
AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astell...
Injectable Drugs133,550 affectedJun 19, 2013
High RiskFDA
Biosense Webster, Inc.
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Cardiac Devices10 affectedJun 19, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5...
Medical Implants85 affectedJun 19, 2013
RecallFDA
Beekley Corporation
Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
Medical Devices81 affectedJun 19, 2013
High RiskFDA
Edwards Lifesciences, Llc
Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are inten...
Surgical Devices99 affectedJun 19, 2013
High RiskFDA
Zimmer, Inc.
Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item code...
Medical Implants85 affectedJun 19, 2013
High RiskFDA
Carestream Health Inc.
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The...
Medical Devices331 affectedJun 19, 2013
High RiskFDA
Philips Healthcare Inc.
Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6...
Cardiac Devices66,150 affectedJun 19, 2013
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating...
Surgical Devices4 affectedJun 19, 2013
High RiskFDA
Novartis Consumer Health
NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, ...
Drugs0 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine...
Drugs0 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and ph...
Drugs917,400 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride...
Drugs292,320 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berr...
Drugs0 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powde...
Drugs1,871,122 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder ...
Drugs1,202,960 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-cou...
Drugs1,140,564 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder pack...
Drugs0 affectedJun 18, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01
Oral Drugs7,579 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powd...
Drugs868,104 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg...
Drugs0 affectedJun 18, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01
Oral Drugs16,293 affectedJun 18, 2013
High RiskFDA
Teva Pharmaceuticals Usa, Inc.
Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01
Oral Drugs13,478 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Sou...
Drugs0 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per...
Drugs398,208 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) pow...
Drugs3,753,348 affectedJun 18, 2013
Medium RiskFDA
Teva Pharmaceuticals Usa, Inc.
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manuf...
Oral Drugs109,080 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, le...
Drugs0 affectedJun 18, 2013
High RiskFDA
Novartis Consumer Health
Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural A...
Drugs1,614,564 affectedJun 18, 2013
High RiskFDA
Invacare Corporation
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in pers...
Medical Devices285 affectedJun 18, 2013
High RiskFDA
Hospira Inc.
LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NO...
Medical Devices14,400 affectedJun 18, 2013
High RiskFDA
Aesculap, Inc.
ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to a...
Medical Implants9 affectedJun 18, 2013
High RiskFDA
Physicians Total Care, Inc.
Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropi...
Oral Drugs270 affectedJun 17, 2013
CriticalFDA
Advance Pharmaceutical Inc
ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC...
Oral Drugs16,440 affectedJun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material an...
Medical Devices7 affectedJun 17, 2013
High RiskFDA
Nanosphere, Inc.
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tes...
Diagnostic Devices20 affectedJun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and ...
Medical Devices3 affectedJun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and ...
Medical Devices2 affectedJun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and desi...
Medical Devices2 affectedJun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and de...
Medical Devices1 affectedJun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and ...
Medical Devices1 affectedJun 17, 2013
CriticalFDA
Lemaitre Vascular, Inc.
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and ...
Medical Devices3 affectedJun 17, 2013