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

Have an unsafe medication, device, or food to report?

Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.

How to report to FDA →
68,659 recalls
High RiskFDA
Meijer Distribution, Inc
Meijer Yogurt Blended Low-fat Blueberry 6 oz.The products are packaged in a plastic cup with a foil seal and a label listing the UPCs.
Dairy·15,084 affected·Feb 5, 2018
RecallFDA
Genentech, Inc.
Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach ...
Oral Drugs·3,192 affected·Feb 5, 2018
RecallFDA
Sun Pharmaceutical Industries, Inc.
Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbu...
Inhaled / Nasal Drugs·17,554 affected·Feb 5, 2018
High RiskFDA
Pharmedium Services, Llc
0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 250 mL Yellow Cassette, Rx only, PharMEDium Serivces, LLC
Drugs·21 affected·Feb 5, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Is...
Oral Drugs·1,157,095 affected·Feb 5, 2018
High RiskFDA
Pharmedium Services, Llc
100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe, Rx only, PharMEDium Serivces, LLC
Injectable Drugs·500 affected·Feb 5, 2018
High RiskFDA
Pharmedium Services, Llc
15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC
Injectable Drugs·24 affected·Feb 5, 2018
High RiskFDA
Icu Medical, Inc.
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, It...
Surgical Devices·11,500 affected·Feb 5, 2018
High RiskFDA
Icu Medical, Inc.
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, St...
Surgical Devices·7,600 affected·Feb 5, 2018
High RiskFDA
Hyphen Biomed
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype...
Diagnostic Devices·60 affected·Feb 5, 2018
High RiskFDA
Icu Medical, Inc.
5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The...
Surgical Devices·100 affected·Feb 5, 2018
High RiskFDA
Ross Acquisitions Company
STAR WARS TIN WITH CARAMEL POPCORN NET WT 3.5 oz (99g) CONTAINS MILK AND SOY, MAY CONTAIN TREE NUTS AND PEANUTS DISTRIBUTED BY GALERIE HE...
Dairy·9,800 affected·Feb 2, 2018
High RiskFDA
Kanan Enterprises, Inc.
SOUTHERN GROVE ALMONDS Unsalted 14 oz (397g) pouch bag INGREDIENTS: ALMONDS. Distributed by ALDI Inc. Batavia, IL 60510 UPC 0 41498 24647 1
Food·1 affected·Feb 2, 2018
RecallFDA
Aurobindo Pharma Ltd.
Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 N...
Oral Drugs·7,476 affected·Feb 2, 2018
RecallFDA
Allergan
NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, In...
Oral Drugs·8 affected·Feb 2, 2018
High RiskFDA
Shippert Medical Technologies
Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medic...
Medical Devices·6,553 affected·Feb 2, 2018
High RiskFDA
Merit Medical Systems, Inc.
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Medical Devices·22,234 affected·Feb 2, 2018
High RiskFDA
Shippert Medical Technologies
Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medica...
Medical Devices·6,553 affected·Feb 2, 2018
High RiskFDA
3m Company - Health Care Business
3M Surgical Clipper Professional 9681
Surgical Devices·120,000 affected·Feb 2, 2018
High RiskFDA
Shippert Medical Technologies
Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical ...
Medical Devices·6,553 affected·Feb 2, 2018
High RiskFDA
Shippert Medical Technologies
Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical ...
Medical Devices·6,553 affected·Feb 2, 2018
CriticalFDA
J F C International Inc
Daisho Kimchi Hot Pot Soup Base; 1.60 lb pouch (10 units per case) Bar Code: 49 04621 04221 9 Product of Japan Imported by JFC Int...
Food·2,563 affected·Feb 1, 2018
High RiskFDA
Olde Thompson, Inc.
Olde Thompson Sweet & Smoky BBQ Grinder NET WT. 6.7 oz. (189.9g) Olde Thompson Oxnard, CA Ingredients: Sea Salt, demerara sugar,...
Food·2,514 affected·Feb 1, 2018
High RiskFDA
Improper Goods
Hibiscus Lavender Syrup, packaged in 100 mL or 250 mL glass bottle. 100 mL bottle has UPC 8 53142 00505 7. 250 mL bottle has UPC 8 531...
Beverages·191 affected·Feb 1, 2018
High RiskFDA
Improper Goods
Lemon Ginger Syrup, packaged in 100 mL or 250 mL glass bottle. 100 mL bottle has UPC 8 53142 00504 0. 250 mL bottle has no UPC code. ...
Beverages·373 affected·Feb 1, 2018
High RiskFDA
Medline Industries Inc
Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.
Surgical Devices·90,870 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 6 (Model 10165888)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Natus Neurology Inc
Nicolet¿ Ambulatory EEG
Medical Devices·171 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective 16 (Model 10891666)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective (Model 10495568)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Scope Power (Model 10967888)
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Spirit(Model 10045692 )
Medical Devices·0 affected·Feb 1, 2018
High RiskFDA
Cook Inc.
StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
Medical Devices·629 affected·Jan 31, 2018
High RiskFDA
3m Company - Health Care Business
ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
Medical Devices·162,348 affected·Jan 31, 2018
High RiskFDA
Cook Inc.
StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606;...
Medical Devices·12,556 affected·Jan 31, 2018
High RiskFDA
Cook Inc.
StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
Medical Devices·470 affected·Jan 31, 2018
High RiskFDA
Cook Inc.
StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
Medical Devices·751 affected·Jan 31, 2018
High RiskFDA
3m Company - Health Care Business
FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
Medical Devices·158,179 affected·Jan 31, 2018
High RiskFDA
Sumano's Bakery
Sourdough French: Product number 2044; SKU 61659799; GTIN [00046567600932] ; UPC 831 49000044 20 pieces; Ingredients: Unbleached ...
Bakery & Grains·3,155 affected·Jan 30, 2018
High RiskFDA
Sumano's Bakery
Sourdough Baguette: Product number 2064; SKU 61659798; GTIN [00046567600949]; UPC 831 49000064 20 pieces; Ingredients: Unbleached...
Bakery & Grains·3,155 affected·Jan 30, 2018
High RiskFDA
Millennium Pharmaceuticals Inc.
VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride ...
Injectable Drugs·154,372 affected·Jan 30, 2018
High RiskFDA
Orthofix Srl
TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX ...
Surgical Devices·408 affected·Jan 30, 2018
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic t...
Diagnostic Devices·6,000 affected·Jan 30, 2018
High RiskFDA
Encore Medical, Lp
AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical ...
Medical Implants·387 affected·Jan 30, 2018
High RiskFDA
Kingston Pharma Llc
Live Better Drug Free Black Elderberry Syrup, 4 FL OZ (118 mL); DIETARY SUPPLEMENT, UPC 050428581186
Produce·13,536 affected·Jan 29, 2018
High RiskFDA
Despana Brand Foods
DON BOCARTE ARTE EN EL PALADAR MIGAS BONITO DEL NORTE PESCA SELECTA DEL CANTABRICO; UPC: 8 43700227144
Food·120 affected·Jan 29, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, IN...
Oral Drugs·34,125 affected·Jan 29, 2018
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-12...
Oral Drugs·12,579 affected·Jan 29, 2018