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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
Nextremity Solutions
Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
Surgical Devices·239 affected·Feb 10, 2022
High RiskFDA
Nextremity Solutions
Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
Surgical Devices·285 affected·Feb 10, 2022
High RiskFDA
Ponder Foods Llc
Pretty Thai Sweet Chili Stir Fry & Barbecue Sauce NET WT. 11.2 oz (317g) UPC 860043001224 packaged in a cylindrical clear PET plastic bo...
Food·919 affected·Feb 9, 2022
CriticalFDA
Concord Farms, Inc.
Fresh Enoki Mushrooms 5.25oz/150 g/ 34 packages per case UPC: 001958939091 Distributed by Concord Farms, Vernon, CA Do not eat ...
Food·800 affected·Feb 9, 2022
High RiskFDA
Lannett Company, Inc.
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc.,...
Oral Drugs·23,598 affected·Feb 9, 2022
CriticalFDA
Walmart Stores
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
Oral Drugs·0 affected·Feb 9, 2022
High RiskFDA
Maquet Cardiovascular, Llc
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Medical Devices·60 affected·Feb 9, 2022
High RiskFDA
Wright Medical Technology, Inc.
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2....
Medical Devices·12 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
Medical Devices·199 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
Medical Devices·2,158 affected·Feb 9, 2022
High RiskFDA
Biomerieux, Inc.
VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Medical Devices·480 affected·Feb 9, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
Medical Devices·6,606 affected·Feb 9, 2022
CriticalFDA
Jan Fruits, Inc.
Taiwan Best Quality Enoki Natural Mushrooms, Premium 200g/7.5 oz. clear plastic package. 50 pcs per box. Manufacturer: Changhua Cou...
Produce·617 affected·Feb 8, 2022
CriticalFDA
Abc Sales 1 Inc
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
Oral Drugs·565 affected·Feb 8, 2022
CriticalFDA
Your Favorite Shop
THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.
Oral Drugs·12,500 affected·Feb 8, 2022
CriticalFDA
Celebrate Today
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Oral Drugs·500 affected·Feb 8, 2022
CriticalFDA
Abc Sales 1 Inc
MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
Oral Drugs·336 affected·Feb 8, 2022
High RiskFDA
Candies Tolteca
Tolteca Saladitos con Chile Limon, Dried Plums with Chili & Lemon; Net Wt. .15 oz. (42.5g) packaged in a clear cellophane bag approximate...
Produce·1,248 affected·Feb 7, 2022
High RiskFDA
Candies Tolteca
Tolteca Saladitos Salted Dried Plums; Net Wt. 1.5 oz. (42.5g) packaged in a clear cellophane bag approximately (4 x 8 ). The name SALAD...
Produce·1,248 affected·Feb 7, 2022
CriticalFDA
Garden-fresh Foods, Inc.
Weis Original Potato Salad, Net Wt 64 oz (4 lb) 1.81kg. UPC 41497-19347. Keep Refrigerated
Produce·372 affected·Feb 7, 2022
CriticalFDA
Mohammad Mayha
Jaguar Power Honey packaged in a gold paper box with black writing, 12 sachets per box UPC 3553314142227
Food·200 affected·Feb 7, 2022
High RiskFDA
American Gourmet
American Gourmet Saladitos (Dried Salted Plums) 1.5 oz. package UPC: 1578600104
Produce·193 affected·Feb 7, 2022
CriticalFDA
Mohammad Mayha
Helmi Honey VIP packaged in a gold paper box with black writing, 12 sachets per box UPC 3553314122014
Food·200 affected·Feb 7, 2022
High RiskFDA
Sun Pharmaceutical Industries Inc
Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 1...
Oral Drugs·59,232 affected·Feb 7, 2022
High RiskFDA
Rising Pharmaceuticals
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle ...
Oral Drugs·2,220 affected·Feb 7, 2022
High RiskFDA
Tsm Brands Llc
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 86...
Drugs·135 affected·Feb 7, 2022
High RiskFDA
Teligent Pharma, Inc.
Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McK...
Topical Drugs·11,040 affected·Feb 7, 2022
High RiskFDA
Tsm Brands Llc
70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Ma...
Drugs·1 affected·Feb 7, 2022
High RiskFDA
Philips North America, Llc
The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 2107...
Medical Devices·478,931 affected·Feb 7, 2022
High RiskFDA
Brius Technologies Inc.
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Devi...
Medical Devices·4 affected·Feb 7, 2022
High RiskFDA
Rojas Inc.
LUPAG brand Plain Dried Salted Plums, net wt. 0.5oz, pre-priced at $.99 packaged in transparent poly bags sealed with a cardboard header,...
Food·833 affected·Feb 6, 2022
CriticalFDA
Golden Medal Mushroom Inc
Enoki Mushrooms, brand Xuerong, net wt. 200g/7.05-ounce packages, UPC 6 953150 100684. Product sent to distributor is packaged in ...
Food·36 affected·Feb 4, 2022
CriticalFDA
Junp Hydration Llc
MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
Oral Drugs·750 affected·Feb 4, 2022
High RiskFDA
Professional Disposables International, Inc.
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Eac...
Drugs·160,531 affected·Feb 4, 2022
High RiskFDA
Professional Disposables International, Inc.
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.17...
Drugs·9,518 affected·Feb 4, 2022
CriticalFDA
Coopersurgical, Inc
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek poly...
Drugs·48,645 affected·Feb 4, 2022
High RiskFDA
Professional Disposables International, Inc.
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. ...
Drugs·28,201 affected·Feb 4, 2022
CriticalFDA
Ev3 Inc.
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Medical Devices·245 affected·Feb 4, 2022
High RiskFDA
Philips North America Llc
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Cardiac Devices·1,696,047 affected·Feb 4, 2022
RecallFDA
Cytocell Ltd.
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosom...
Medical Devices·1 affected·Feb 4, 2022
High RiskFDA
Philips North America Llc
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STER...
Cardiac Devices·331,712 affected·Feb 4, 2022
High RiskFDA
A & E Corrales Llc
Saladitos With Chili, Net Weight 16 oz (1lb) with UPC 0661799748162. The product is packaged in ultra clear sealed zip-lock plastic bag....
Produce·12 affected·Feb 3, 2022
High RiskFDA
Pacific Golden Coast Trading Inc
Dried salted plum, packaged in 22 lbs. carton. Product of China.
Food·820 affected·Feb 3, 2022
CriticalFDA
Whole Foods Market Brand 365, Llc
Whole Foods Market Vanilla Short Bread Cookies packaged in clear plastic container with a white scale label applied PLU 66705
Bakery & Grains·23 affected·Feb 3, 2022
CriticalFDA
Staq Pharma, Inc.
HYDROmorphone HCl PF 10 mg/50 mL (0.2mg/mL) in NaCl, 50 mL in 50 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, ND...
Drugs·905 affected·Feb 3, 2022
CriticalFDA
Staq Pharma, Inc.
Morphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: ...
Drugs·0 affected·Feb 3, 2022
High RiskFDA
Abbott Laboratories, Inc
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro di...
Diagnostic Devices·306 affected·Feb 3, 2022
High RiskFDA
El Chavito
El Chavito¿ Saladitos Dried Salted Plums, net wt. 1.7 oz bag, Individual UPC 859470006049, Master Case UPC 859470006629. El Chavito¿ Sal...
Produce·37,552 affected·Feb 2, 2022