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
High RiskFDA
Hologic, Inc
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker i...
Medical Implants·233 affected·Aug 9, 2022
RecallFDA
Yem Foods Llc
Priyems Sambar Spicy Lentil Soup 800 grams (1.76 lbs) UPC 8 61754 00010 0, 8 retail units per wholesale case, Frozen
Frozen Food·2,313 affected·Aug 8, 2022
High RiskFDA
Triple B Corporation
Charlie's brand perishable and refrigerated Spinach Salad With Honey Dijon Dressing, item # 028-09048, packaged in a clear hinged contain...
Beverages·4,438 affected·Aug 8, 2022
RecallFDA
Yem Foods Llc
Priyems Lemon Pickle 1lb/454g UPC 8 61754 000117, 10 retail units per wholesale case, Refrigerated
Food·387 affected·Aug 8, 2022
RecallFDA
Yem Foods Llc
Priyems Mango Pickles 1lb/454g UPC 8 61754 000179, 10 retail units per wholesale case, Refrigerated
Food·731 affected·Aug 8, 2022
RecallFDA
Yem Foods Llc
Priyems Sambar Coconut & Onion Spicy Lentil Soup 800 grams (1.76 lbs) UPC 8 61754 000124, 8 retail units per wholesale case, Frozen
Produce·662 affected·Aug 8, 2022
RecallFDA
Akorn, Inc
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Fore...
Ophthalmic Drugs·5,226 affected·Aug 8, 2022
High RiskFDA
Midlab Incorporated
Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Prod...
Drugs·0 affected·Aug 8, 2022
High RiskFDA
Midlab Incorporated
Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b...
Drugs·892 affected·Aug 8, 2022
High RiskFDA
Ethicon, Inc.
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Medical Devices·88 affected·Aug 8, 2022
High RiskFDA
Gs Biomark Llc
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 ...
Diagnostic Devices·639,200 affected·Aug 8, 2022
CriticalFDA
Blue Diamond Growers
Whole Brown Almonds (bulk)
Food·347,650 affected·Aug 5, 2022
High RiskFDA
Datascope Corporation
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Surgical Devices·4,414 affected·Aug 5, 2022
High RiskFDA
Datascope Corporation
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Surgical Devices·10,427 affected·Aug 5, 2022
High RiskFDA
Datascope Corporation
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Surgical Devices·10,427 affected·Aug 5, 2022
High RiskFDA
That's It. Nutrition, Lcc
That's It. Dark Chocolate Raisin Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Raisins, Organic Dark Chocolate (Organ...
Dairy·0 affected·Aug 4, 2022
High RiskFDA
That's It. Nutrition, Lcc
That's It. Dark Chocolate Fig with Sea Salt Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Figs, Organic Dark Chocola...
Dairy·0 affected·Aug 4, 2022
High RiskFDA
That's It. Nutrition, Lcc
That's It. Dark Chocolate Fig Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Figs, Organic Dark Chocolate (Organic Uns...
Dairy·0 affected·Aug 4, 2022
High RiskFDA
That's It. Nutrition, Lcc
That's It. Dark Chocolate Banana Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Bananas, Organic Dark Chocolate (Organ...
Dairy·0 affected·Aug 4, 2022
High RiskFDA
That's It. Nutrition, Lcc
That's It. Dark Chocolate Date Truffles Net WT. 3.5 oz, 5.0 oz, and 16.0 oz Ingredients: Organic Dates, Organic Dark Chocolate (Organic U...
Dairy·0 affected·Aug 4, 2022
Medium RiskFDA
Lnk International, Inc.
Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS ...
Oral Drugs·257,064 affected·Aug 4, 2022
RecallFDA
Akron Pharma, Inc.
Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02...
Oral Drugs·30,325 affected·Aug 4, 2022
Medium RiskFDA
Akron Pharma, Inc.
Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharm...
Oral Drugs·301,382 affected·Aug 4, 2022
High RiskFDA
Baxter Healthcare Corporation
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only...
Injectable Drugs·85,680 affected·Aug 4, 2022
RecallFDA
Eclectic Institute Inc
Eclectic Herb Vitamin Herb Blend vita biotic dietary supplement, 750mg, 150 capsules per plastic bottle, UPC 0 23363 52002 2. Eclectic In...
Produce·1,334 affected·Aug 3, 2022
High RiskFDA
Collagen Matrix Inc
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytopla...
Medical Devices·1,336 affected·Aug 3, 2022
High RiskFDA
Merit Medical Systems, Inc.
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CO...
Medical Devices·1,822 affected·Aug 3, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (...
Surgical Devices·136,080 affected·Aug 3, 2022
CriticalFDA
Royal Crest Dairy, Incorporated
Farmer's All Natural 2% Reduced Fat Chocolate Milk, One Pint (473 mL), Packaged in food safe, single-trip, polyethylene plastic bottles. ...
Dairy·8 affected·Aug 2, 2022
High RiskFDA
Cipla
Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured ...
Ophthalmic Drugs·7,992 affected·Aug 2, 2022
RecallFDA
Heron Therapeutics, Inc.
Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufac...
Drugs·1,790 affected·Aug 2, 2022
High RiskFDA
Carwild Corporation
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Numb...
Medical Devices·90 affected·Aug 2, 2022
High RiskFDA
H-e-b Grocery Company, Lp Dba Heb Milk & Culture Plant #80645
HEB Creamy Creations Light 1/1 The Fat 1/3 Fewer Calories Of Regular Ice Cream Mint Chocolate Chip Ice Cream Half Gallon (1.89L) UPC 4122...
Dairy·880 affected·Aug 1, 2022
High RiskFDA
Akorn, Inc
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Oral Drugs·14,712 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administratio...
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
Medical Devices·19,925 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
Medical Devices·9,900 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL....
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or art...
Surgical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Medical Devices·100 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Medical Devices·37,550 affected·Aug 1, 2022
High RiskFDA
Merchsource Llc
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength ...
Medical Devices·0 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Carefusion
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Medical Devices·54,050 affected·Aug 1, 2022
High RiskFDA
Randox Laboratories Ltd.
The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsA...
Medical Devices·2 affected·Aug 1, 2022
High RiskFDA
Russ Davis Wholesale, Llc
Dragon Fruit Mix. Contains: Mango, Dragon Fruit, Pineapple, Clementines, Blueberries. Keep Refrigerated. Item 89348. Net Wt. 16 o...
Produce·87,915 affected·Jul 29, 2022
CriticalFDA
Kingdom Creamery Of Vermont Llc
Kingdom Creamery of Vermont 5% Maple Soft Serve Mix
Food·1,623 affected·Jul 29, 2022