Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

1226–1250 of 26417

HighFDA (Devices)·Z-1481-2026·2026-03-11
B. Braun Winged Infusion Needle Recalled for Dull or Broken Needle Tips
B. Braun is recalling approximately 105,550 BBraun Medical 21G X4.4CM Winged Infusion Needles due to potential for needle tips to be dull, blunt, or prone to breaking.
Product
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percut
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1478-2026·2026-03-11
ShockPulse-SE Lithotripsy System may fail to recognize transducer probe
Olympus recalled ShockPulse-SE Lithotripsy Systems where the generator fails to recognize the transducer probe. The issue affects 1,082 units distributed worldwide.
Product
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0383-2026·2026-03-11
Midodrine Hydrochloride Tablets Recalled for Defective Blister Packaging
The FDA is recalling Midodrine Hydrochloride 5mg tablets due to defective, inadequately sealed blister packaging. The recall affects 8,892 cartons distributed nationwide.
Product
MIDODRINE HYDROCHLORIDE — MIDODRINE HYDROCHLORIDE (MIDODRINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1492-2026·2026-03-11
Vascular Prostheses Recalled Due to Incorrect Expiration Date Labeling
Vascutek vascular prostheses (Gelsoft Plus and Gelweave) were mislabeled with incorrect expiration dates, with devices marked to expire one month later than they actually will. The labeling used packaging date instead of gel impregnation date for shelf-life calculation.
Product
Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0380-2026·2026-03-11
Semaglutide compounding ingredient recalled for unvalidated manufacturing processes
Harbin Jixianglong Biotech is recalling semaglutide raw ingredient used for pharmacy compounding due to incomplete process and endotoxin testing validation before distribution.
Product
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0395-2026·2026-03-11
FDA Recalls Tirzepatide Injectables Due to Sterility Defect
New Life Pharma LLC recalled 45 vials of Tirzepatide 15mg injectable due to lack of assurance of sterility. The affected lot was distributed in Ohio.
Product
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0373-2026·2026-03-11
Hand Sanitizing Wipes Recalled for Manufacturing Compliance Deviations
Acme United Corporation is voluntarily recalling First Aid Only Hand Sanitizing Wipes nationwide due to manufacturing process deviations. No injuries or illnesses have been reported.
Product
FIRST AID ONLY HAND SANITIZING WIPE — FIRST AID ONLY HAND SANITIZING WIPE (ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0386-2026·2026-03-11
4% Lidocaine Cream Recalled Due to Inadequate Stability Data
Lidocaine cream lacking stability data to support its expiry date is being recalled nationwide. Consumers should stop using affected bottles and consult their pharmacist.
Product
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0368-2026·2026-03-11
Hand sanitizing wipes recalled due to manufacturing practice deviations
ACME UNITED CORPORATION has voluntarily recalled Wipes Plus hand sanitizing wipes due to CGMP deviations. No illnesses have been reported.
Product
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0392-2026·2026-03-11
Semaglutide Injectable Recalled for Lack of Sterility Assurance
New Life Pharma LLC is recalling Semaglutide 2mg sterile injectable vials due to lack of assurance of sterility. Two lots distributed in Ohio are affected.
Product
Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
Category
Drug
Distribution
1 state
HighFDA (Drugs)·D-0389-2026·2026-03-11
Prescription Drug Recall: Sodium Iodide I-131 Contaminated with Particulate Matter
Radnostix recalls Sodium Iodide I-131 oral solution (FDA Class II) due to particulate matter contamination from production issues. Affected product was distributed nationwide in the USA and Puerto Rico.
Product
SODIUM IODIDE I-131 — SODIUM IODIDE I-131 (SODIUM IODIDE I-131)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0355-2026·2026-03-11
Metoprolol Succinate Extended-Release Tablets Recalled for Dissolution Failure
Teva Pharmaceuticals is recalling 67,043 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg nationwide due to failed dissolution specifications. Affected tablets may not release medication properly in the body.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0357-2026·2026-03-11
Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution
Teva Pharmaceuticals recalls Metoprolol Succinate Extended-Release Tablets (200 mg) due to failed dissolution specifications. The recall affects 19,056 bottles distributed nationwide.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1489-2026·2026-03-11
Olympus Single Use Biopsy Valve Recalled Due to Rubber Fragment Detachment Risk
Olympus is recalling its Single Use Biopsy Valve (Model MAJ-1218) due to potential rubber fragments detaching during use. The product has been distributed nationwide.
Product
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0354-2026·2026-03-11
Metoprolol succinate tablets recalled for failed dissolution specifications
Teva Pharmaceuticals is recalling 18,780 bottles of metoprolol succinate extended-release tablets nationwide due to failed dissolution specifications that may reduce medication effectiveness.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0372-2026·2026-03-11
Hand sanitizing wipes recalled due to manufacturing practice deviations
ACME UNITED CORPORATION is recalling WP WipesPlus Hand Sanitizing Wipes nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The company voluntarily initiated the recall following FDA notification.
Product
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0540-2026·2026-03-11
VERGANI 1944 MILANO Pandoro Classico Gluten Free Cake Recall
Italianway Import, Inc. is recalling VERGANI 1944 MILANO Pandoro Classico Gluten Free cake due to potential contamination with Teflon fragments from flaking cooking molds.
Product
VERGANI 1944 MILANO 'PANDORO CLASSICO' Gluten Free, 600g NET WT. 1 LBS. 5.2 OZ., packaged in paper cartons, 6 units per case. Lot 217666, UPC 8002114019833
Category
Food
Distribution
3 states
HighFDA (Drugs)·D-0399-2026·2026-03-11
Amnesteem Isotretinoin 40 mg Capsules Recalled Due to Failed Dissolution Specifications
Mylan Pharmaceuticals is recalling Amnesteem (isotretinoin) 40 mg capsules due to failed dissolution specifications, which may affect medication effectiveness. The recall affects 34,850 blister packs distributed nationwide.
Product
AMNESTEEM — AMNESTEEM (ISOTRETINOIN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0385-2026·2026-03-11
Vasocaine Spray Recalled Due to Unsupported Expiration Dates
HTO Nevada Inc. is recalling FIVE-STAR VASOCAINE Spray because stability data does not support the stated expiration dates on 27,380 bottles distributed nationwide.
Product
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1488-2026·2026-03-11
Olympus Biopsy Valve Recalled Due to Potential Rubber Fragment Detachment
Olympus Corporation is recalling approximately 95,882 boxes of MAJ-210 Single use Biopsy Valves nationwide due to potential for rubber fragments to detach during endoscopic procedures.
Product
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0543-2026·2026-03-11
Junebar Chocolate Cherry Snack Bars Recalled for Undeclared Milk and Soy
Juniper Granola, LLC is recalling Junebar Chocolate Cherry All Natural Snack Bars because they contain undeclared milk and soy, posing a risk to consumers with allergies to these ingredients.
Product
Junebar Chocolate Cherry All Natural Snack Bar; INGREDIENTS: ORGANIC ALMOND BUTTER, DATE PASTE, ORGANIC BLACK BEANS, ORGANIC SWEET POTATOES, GLUTEN FREE ROLLED OATS, SEMI-SWEET SOY FREE VEGAN CHOCOLATE CHIPS (ORGANIC CANE SUGAR, UNSWEETENED CHOCOLATE, COCOA BUTTER), DRIED CHERRIE
Category
Food
Distribution
0 states
HighFDA (Food)·H-0544-2026·2026-03-11
Tippy Toes Baby Food Recalled for Potential Patulin Contamination
Tippy Toes apple pear banana baby food (6 months & up) is being recalled due to potential contamination with patulin. Consumers who have purchased this product should not feed it to infants.
Product
tippy toes apple pear banana 6 months & up baby food 2-4OZ (113g) PACKS NET WT 8 OZ (226g) DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 1-888-423-0139 PRODUCT OF USA UPC: 036800265783
Category
Food
Distribution
1 state
HighFDA (Food)·H-0542-2026·2026-03-11
Junebar Peanut Chocolate Chip Snack Bars Recalled for Undeclared Milk and Soy
Juniper Granola is recalling Junebar Peanut Chocolate Chip All Natural Snack Bars because they contain undeclared milk and soy, which pose a risk to consumers with allergies to these ingredients.
Product
Junebar Peanut Chocolate Chip All Natural Snack Bar; INGREDIENTS: ORGANIC PEANUT BUTTER, DATE PASTE, ORGANIC BLACK BEANS, ORGANIC SWEET POTATOES, GLUTEN FREE ROLLED OATS, SEMI-SWEET SOY FREE VEGAN SHOCOLATE CHIPS (ORGANIC CANE SUGAR, UNSWEETENED CHOCOLATE, COCOA BUTTER), PEANUTS,
Category
Food
Distribution
0 states
HighFDA (Food)·H-0574-2026·2026-03-11
Karns Foods Mini Dark Chocolate Raspberry Cups recalled for undeclared peanuts
Karns Prime And Fancy Foods is recalling Mini Dark Chocolate Raspberry Cups because they may contain undeclared peanuts. The product was distributed only in Pennsylvania.
Product
Karns Foods, Mini Dark Chocolate Raspberry Cups, 8 oz Clear plastic tamper evident packs, 36-42 packed per breakout
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1475-2026·2026-03-11
GE Healthcare Centricity Universal Viewer: Patient Information May Not Match Images
GE Healthcare is recalling Centricity Universal Viewer Zero Footprint Client software versions ZFP v6.0 SP11.6, SP11.6.0.1, and SP11.6.1 due to a data integrity issue where patient information may not match displayed images on systems with Patient Timeline installed.
Product
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
Category
Medical Device
Distribution
Distributed nationwide