Recall Register

Food, drug and device recalls

FDA enforcement reports from openFDA, with the records of one event on one page. Export of .

Recall classes

In the words of FDA.

FDA: It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

Class I
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Class II
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class III
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
FDA enforcement events on the register, by class
ClassEvents
Class II20,346
Class I4,894
Class III2,371
Unclassified2

What FDA recall classes mean

Newest food recalls

The 15 newest FDA food enforcement events with a page
InitiatedProduct (first record)Recalling firmTypeClassRecords
3 Sep 2026Heinz Real - Vraie Mayonnaise, 12.5ml single serving packet, 500 packets per case, case code 57000 06672KRAFT HEINZ FOODS COMPANYFoodNot yet classified1
28 Aug 2026Hexing Haw Balls candy; packaged in 200g/0.44 lb./7.05 oz clear plastic bag; Ingredients: haw, white sugar, water.; Serving suggestion: ready to eat. Storage: keep in cool and dry place and keep tightly closed in refrigerator after opening.; PRODUCT OF CHINA; UPC 6 920603 810025Tiffany Food CorpFoodClass III1
22 Aug 2026Everything Sprouts and Calco branded Alfalfa Sprouts, Net Wt. 5.0 oz (142 g) UPC 7 68944-00005 9. The 5 oz. containers are distributed as single units, or in a tray with 6 - 5oz containers that contains UPC 8 60014-52312 0 label on bottom of tray, or in a try with 12 - 5 oz. containers that contains UPC 8 60014-52311…Everything Sprouts, LLCFoodClass I4
18 Aug 2026Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.Dreyer's Grand Ice Cream Inc.FoodClass II6
13 Aug 2026Prince ITALIAN BREAD; Sesame; NET WEIGHT 8 OZ. (227g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR, NIACIN, FERROUS SULFATE, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY HYDROGENATED SOYBEAN, COTTONSEED, AND/OR CANOLA…Prince Bakery IncFoodClass II4
11 Aug 2026Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404Byron White Formulas, Inc.FoodClass II3
10 Aug 2026VITASIA ASIAN STYLE WOK SPICE MIX NET WT 1.58 OZ (45g) UPC 4 335619 355491 DISTRIBUTED BY LIDL US, LLC ARLINGTON, VA 22202 PRODUCT OF THE CZECH REPUBLICLidl US TRADINGFoodClass I1
7 Aug 2026Horizon Organic ORG ASEP CHOC MILK 1% 8OZ 12 CT (Item 136990, UPC 742365002700) and 18 CT (Item 136917, UPC 742365208867). Tetra Pak Carton. Distributed by: Horizon Organic Dairy, LLC ( Horizon ) 12303 Airport Way Suite 200 Broomfield, CO 80021. Shelf Stable, refrigerate after opening.Horizon Organic Dairy, LLCFoodClass II1
7 Aug 2026Whole Foods Mild Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 21211600000, 21501700000, 25705700000, 25054100000, 25926000000 (part of Dip Trio)…WFM Purchasing, LPFoodClass I10
7 Aug 2026Diced Jalapenos. Ingredients: Jalapeno Pepper. Net Wt: 3.75 oz. Keep Refrigerated. Distributed by: Taylor Farms Inc., Salinas, CA 93902. UPC: 030223082712Taylor Fresh Foods IncFoodClass I25
6 Aug 2026Item # DIPPIC0205RFS Pico de Gallo 5 lb packaged in round plastic container.Ron's Home Style Foods, Inc.FoodClass I2
5 Aug 2026PICO DE GALLO-MILD-4oz PICO DE GALLO-MILD-6/14oz PICO DE GALLO-4/5# PICO DE GALLO-1/5# PICO DE GALLO-MILD-1/5#NatureBest Pre-Cut & Produce LLcFoodClass I8
30 Jul 2026Bread Pudding with Vanilla Sauce NET WT 13.8 OZ (39g) UPC 7 22515 28044 8 Ukrop's Homestyle Foods, LLC Richmond, VA 23230Ukrop's Homestyle Foods LLCFoodClass II2
29 Jul 2026KC Everyday Mac & Cheese, 3lb x 6. Item # 20609055. 6 - 3 lb pouches, Net Wt: 18 lb. (8.16Kg). Fully Cooked. Keep Frozen. Distributed By: Kerry Inc, Beloit, WI 53511.Kerry, IncFoodClass I1
28 Jul 2026Wonton Specialist Inc. Pan Fried Noodle, 16 oz and 5lb packaged in clear plastic bagsName withheldFoodClass III6

Newest drug recalls

The 15 newest FDA drug enforcement events with a page
InitiatedProduct (first record)Recalling firmTypeClassRecords
14 Sep 2026Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289-1SUN PHARMACEUTICAL INDUSTRIES INCDrugNot yet classified1
4 Sep 2026Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01.PfizerDrugClass II1
3 Sep 2026fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.OurPharma LLCDrugClass II1
31 Aug 2026Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 USA, NDC 17772-102-30.Supernus Pharmaceuticals, Inc.DrugClass III1
26 Aug 2026Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only,…Mylan Pharmaceuticals IncDrugClass II1
25 Aug 2026Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.Ajanta Pharma USA IncDrugClass III1
24 Aug 2026Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.Hikma Pharmaceuticals USA INC.DrugClass II1
24 Aug 2026traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01Teva Pharmaceuticals USA, IncDrugClass II1
21 Aug 2026Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.Golden State Medical Supply Inc.DrugClass II1
21 Aug 2026Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7Lexia LLCDrugClass II2
19 Aug 2026Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01Chiesi USA, Inc.DrugClass III1
19 Aug 20260.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.B BRAUN MEDICAL INCDrugClass I1
19 Aug 2026Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).American Health PackagingDrugClass III1
17 Aug 2026Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.Mylan Pharmaceuticals IncDrugClass II1
17 Aug 20260.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03Baxter Healthcare CorporationDrugClass I1

Newest device recalls

The 15 newest FDA device enforcement events with a page
InitiatedProduct (first record)Recalling firmTypeClassRecords
20 Aug 2026CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24JP…ICU Medical, Inc.DeviceClass II1
20 Aug 2026Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: NoWilson-Cook Medical Inc.DeviceClass II1
19 Aug 2026NOxBOXi Nitric Oxide Delivery System.NOXBOX LTDDeviceClass II1
19 Aug 2026REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MMStryker Sustainability SolutionsDeviceClass II6
18 Aug 2026POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessoriesOlympus Corporation of the AmericasDeviceClass II1
12 Aug 2026GM Helix Implant, REF: 109.984;Straumann USA LLCDeviceClass II1
12 Aug 2026Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 4. Impella…Abiomed, Inc.DeviceClass I3
11 Aug 2026Baxter Novum IQ Syringe Pump, Model Number 40800BAXUSBaxter Healthcare CorporationDeviceClass II2
11 Aug 2026Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199AMedline Industries, LPDeviceClass I7
10 Aug 20265008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6Fresenius Medical Care Renal Therapies Group, LLCDeviceClass II4
10 Aug 2026Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605240; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605300; Power-Trialysis Short-Term Curved…Bard Access Systems, Inc.DeviceClass I2
10 Aug 2026Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;AVID Medical, Inc.DeviceClass I4
7 Aug 2026Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.Philips North America LlcDeviceClass II4
7 Aug 2026Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);Atrium Medical CorporationDeviceClass II3
7 Aug 2026Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110Happiest Baby, IncDeviceClass II2

Recalling firms

1,615 firms have a page.

The list shows 36 firms with a large number of events, in the order of the alphabet. All 1,615 firms

Events by year

Device enforcement events
15,029
Food enforcement events
7,891
Drug enforcement events
4,693
FDA enforcement events, by the year that the recall started. openFDA has few records before 2012. The largest year is 2016, with 2,319 events.