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
CriticalFDA
Wegmans Food Markets, Inc.
Wegmans Made with No Gluten Containing Ingredients Shortcake Slice; 6oz; UPC: 7789051145
Bakery & Grains682 affectedAug 21, 2020
CriticalFDA
Frito-lay, Inc.
Ruffles Original Potato Chips NET WT 1 1/2 oz. packaged in flexible bags UPC 28400 48228
Snacks & Candy768 affectedAug 21, 2020
High RiskFDA
Handicare Ab
SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts ...
Medical Devices6,716 affectedAug 21, 2020
High RiskFDA
North American Rescue Llc.
4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; ...
Medical Devices11,404 affectedAug 21, 2020
High RiskFDA
The Superior Nut Company, Inc.
SOUTHERN GROVE; MIXED NUTS; LESS THAN 50% PEANUTS; PEANUTS, ALMONDS, CASHEWS, HAZELNUTS, & PECANS; with Sea Salt; NET WT 14.75 OZ (418g);...
Dairy30,936 affectedAug 20, 2020
CriticalFDA
Riviana Foods Inc
RONZONI SINCE 1915 Smart Taste Extra Wide Noodle Style 2.5x the Fiber of Regular Pasta Net Wt. 12OZ (340g). UPC: 7130005008
Food17,356 affectedAug 20, 2020
High RiskFDA
Brainlab Ag
Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
Medical Devices21 affectedAug 20, 2020
CriticalFDA
Wawona Packing Co Llc Dba Prima Wawona
Fresh peaches - sold loose/bulk and Bagged fresh peaches, 2 lbs. plastic pouch under brand names of: Wawona- UPC 033383322001 Wawona ...
Food4,109,325 affectedAug 19, 2020
High RiskFDA
Bayshore Pharmaceuticals
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kath...
Oral Drugs3,984 affectedAug 19, 2020
High RiskFDA
Bayshore Pharmaceuticals
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kat...
Oral Drugs594 affectedAug 19, 2020
High RiskFDA
Ansell Healthcare Products Llc
MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medica...
Medical Devices1,312 affectedAug 19, 2020
High RiskFDA
Grupo Yacana Mexico Sas De Cv
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 71...
Topical Drugs55,560 affectedAug 18, 2020
High RiskFDA
Grupo Yacana Mexico Sas De Cv
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy ...
Topical Drugs43,728 affectedAug 18, 2020
High RiskFDA
Nanomateriales Sa De Cv
Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 53115...
Topical Drugs19,440 affectedAug 18, 2020
High RiskFDA
Nanomateriales Sa De Cv
Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles, Distributed by Fujimura Trading S.A. DE C.V. Juve...
Topical Drugs1,000 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B
Medical Devices99,900 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; ...
Medical Devices13,700 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2...
Medical Devices27,375 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ ED...
Medical Devices3,600 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC5...
Medical Devices26,775 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUP...
Medical Devices31,800 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
Medical Devices47,005 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP ...
Diagnostic Devices31,600 affectedAug 18, 2020
High RiskFDA
Beckman Coulter Inc.
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent f...
Diagnostic Devices219 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/...
Medical Devices189,175 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC...
Medical Devices136,925 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
Medical Devices41,340 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+...
Medical Devices170,425 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+TH...
Medical Devices51,075 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
Medical Devices537,120 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug ...
Medical Devices303,100 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test ...
Medical Devices67,300 affectedAug 18, 2020
High RiskFDA
Ameditech Inc
MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH...
Medical Devices12 affectedAug 18, 2020
CriticalFDA
Ask Foods Inc
A.S.K. Foods, Inc. Lobster Salad (2.5 lb.) with codes of 4472 or 4482 , Bulk Containers / 2 Containers per Case ( Product ), SELL BY: 08-...
Seafood30 affectedAug 17, 2020
CriticalFDA
Maison Terre, Llc
Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net
Drugs670 affectedAug 17, 2020
CriticalFDA
Mylan Institutional Llc
Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per ca...
Injectable Drugs1,407 affectedAug 17, 2020
CriticalFDA
Mylan Institutional Llc
Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials pe...
Injectable Drugs13,682 affectedAug 17, 2020
High RiskFDA
Arthrocare Corporation
Speed Stitch Needle Cassette
Medical Devices6,366 affectedAug 17, 2020
CriticalFDA
Sg24 Llc
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125
Drugs9,600 affectedAug 14, 2020
CriticalFDA
Grupo Asimex De Mexico Sa De Cv
Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles...
Drugs22,680 affectedAug 14, 2020
CriticalFDA
Sg24 Llc
Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette packaged in 2.5 x 3.75 packets, Dist by: SG24 LLC, Bolingbroke, GA...
Drugs122,500 affectedAug 14, 2020
CriticalFDA
Volu-sol, Inc.
Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, ...
Topical Drugs0 affectedAug 14, 2020
CriticalFDA
Sg24 Llc
Skin Guard 24 All-Day Hand Sanitizer 10 mL Pocket Pen Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147097
Drugs10,000 affectedAug 14, 2020
CriticalFDA
Sg24 Llc
SkinGuard 24 All-Day Hand Sanitizer 2.67 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147103
Drugs9,600 affectedAug 14, 2020
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutic...
Injectable Drugs97,890 affectedAug 14, 2020
High RiskFDA
Grupo Asimex De Mexico Sa De Cv
Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles...
Drugs0 affectedAug 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionucl...
Medical Devices412 affectedAug 14, 2020
High RiskFDA
Ge Healthcare, Llc
NM/CT 850 Model Number: H3907AD
Medical Devices25 affectedAug 14, 2020