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
CriticalFDA
Living Well Remedies, Llc
Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin Lakes, NJ 07417...
Drugs·128 affected·Aug 13, 2018
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68...
Oral Drugs·11,706 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623
Surgical Devices·50 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
Medical Devices·48 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
Medical Devices·150 affected·Aug 13, 2018
High RiskFDA
Biomerieux, Inc.
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobial...
Medical Implants·10,919 affected·Aug 13, 2018
High RiskFDA
Stryker Spine
AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devi...
Medical Devices·5 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664
Medical Devices·48 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B
Medical Devices·24 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
Medical Devices·72 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
Medical Devices·100 affected·Aug 13, 2018
High RiskFDA
Biomerieux, Inc.
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobial...
Medical Implants·2,538 affected·Aug 13, 2018
CriticalFDA
Stryker Medical Division Of Stryker Corporation
IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and trea...
Medical Devices·243 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: YMCIR-400
Medical Devices·300 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112
Medical Devices·4,500 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECI...
Medical Devices·72,832 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
Medical Devices·1,250 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
Medical Devices·630 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591
Medical Devices·150 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
Surgical Devices·50 affected·Aug 13, 2018
High RiskFDA
Remel Inc
remel THIOGLYCOLLATE MEDIUM, REF 05152
Medical Devices·48 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
Medical Devices·50 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
Medical Devices·30 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
Medical Devices·250 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number...
Medical Devices·1 affected·Aug 13, 2018
High RiskFDA
Custom Healthcare Systems, Inc.
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
Medical Devices·80 affected·Aug 13, 2018
High RiskFDA
The Binding Site Group, Ltd.
VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage:...
Diagnostic Devices·462 affected·Aug 12, 2018
High RiskFDA
Westlab Pharmacy, Inc. Dba Westlab Pharmacy
Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
Ophthalmic Drugs·7 affected·Aug 10, 2018
High RiskFDA
Remedyrepack Inc.
Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 1570...
Oral Drugs·21 affected·Aug 10, 2018
High RiskFDA
Westlab Pharmacy, Inc. Dba Westlab Pharmacy
ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1c...
Drugs·222 affected·Aug 10, 2018
High RiskFDA
Remedyrepack Inc.
Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 1570...
Oral Drugs·36 affected·Aug 10, 2018
High RiskFDA
Westlab Pharmacy, Inc. Dba Westlab Pharmacy
Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
Injectable Drugs·80 affected·Aug 10, 2018
High RiskFDA
Remedyrepack Inc.
Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4, Indiana, PA 15701...
Oral Drugs·9 affected·Aug 10, 2018
RecallFDA
Medtest Holdings, Inc.
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific ...
Diagnostic Devices·22 affected·Aug 10, 2018
High RiskFDA
A M Systems Inc
Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 L...
Respiratory Devices·610 affected·Aug 10, 2018
High RiskFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vas...
Surgical Devices·67 affected·Aug 10, 2018
High RiskFDA
Deli Star Ventures Inc. Dba King's Food Products
Chef s Request professional steak marinade and Buckhead wildlife marinade, 12oz, 64oz, 1 gallon; shelf stable, refrigerate after opening
Food·4,715 affected·Aug 9, 2018
RecallFDA
Orexigen Therapeutics, Inc.
Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen ther...
Oral Drugs·95,296 affected·Aug 9, 2018
High RiskFDA
Biomet Uk Ltd.
HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: Th...
Medical Devices·10 affected·Aug 9, 2018
High RiskFDA
Biomet Uk Ltd.
HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: Th...
Medical Devices·6 affected·Aug 9, 2018
High RiskFDA
Biomet Uk Ltd.
HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: Th...
Medical Devices·1 affected·Aug 9, 2018
High RiskFDA
Besmed Health Business Corporation
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Medical Devices·267 affected·Aug 9, 2018
High RiskFDA
Morgan Foods, Inc.
Tomato Condensed Soup, 26 oz (1 LB 10 OZ) 737 g, 307 x 512 Can, Family Size, 12 cans per tray, shelf stable
Produce·6,168 affected·Aug 8, 2018
RecallFDA
Akorn, Inc.
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest...
Ophthalmic Drugs·8,574 affected·Aug 8, 2018
High RiskFDA
Hetero Labs Limited Unit V
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscata...
Oral Drugs·441,408 affected·Aug 8, 2018
High RiskFDA
Hetero Labs Limited Unit V
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscatawa...
Oral Drugs·316,380 affected·Aug 8, 2018
High RiskFDA
Hetero Labs Limited Unit V
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataw...
Oral Drugs·441,408 affected·Aug 8, 2018
High RiskFDA
Hetero Labs Limited Unit V
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Pi...
Oral Drugs·394,896 affected·Aug 8, 2018