
FDA•MODERATE
Duloxetine Delayed-Release Capsules 60mg
Breckenridge Pharmaceutical is recalling Duloxetine 60mg capsules distributed nationwide due to the presence of an impurity above FDA limits.

Breckenridge Pharmaceutical is recalling Duloxetine 60mg capsules distributed nationwide due to the presence of an impurity above FDA limits.

Publix Bran Flakes Wheat Cereal recalled over possible plastic contamination.

Acella Pharmaceuticals is recalling Naproxen Oral Suspension, 125 mg/5mL, distributed nationwide due to lead and lithium contamination.

BioFire is recalling the Joint Infection (JI) Panel due to contamination that may cause false positive test results.
Mint Medical is recalling Mint Lesion software versions 3.4.0–3.9.5 due to a risk of data loss or incorrect patient information linking.

One Step 10A in vitro diagnostic test recalled for lack of FDA clearance.
7 products
BioFire is recalling the Spotfire Respiratory/Sore Throat Panel due to the risk of false negative results and control failures.

Katalyst Surgical recalls DEX Ophthalmic Tissue Forceps, model DVF4005-23, due to IFU corrective action.
12 products
My Wife's Slaw (original and Jalapeno Heat) recalled for lack of approved food establishment inspection.
2 products
Market of Choice recalls Vegan Kale Caesar Salad over undeclared sesame allergen.

Winfield's CWB Chocolate Bars recalled over undeclared milk allergen.

Cronus Pharma is recalling Amoxicillin and Clavulanate Potassium oral suspension drops for dogs and cats due to product discoloration.
2 products
Woodstock Organic Shelled Edamame recalled over possible metal pieces.

Teva is recalling Octreotide Acetate 30 mg injection kits due to a lack of assurance of sterility.
2 products
Rising Pharma is recalling Enalapril Maleate 20 mg tablets (NDC 64980-688-10) due to failed impurities test.

CareFusion is recalling BD PurPrep sterile solution due to a lack of assurance of sterility and potential product contamination.
2 products
Walker Honey recalls Fain's creamed honey spreads over possible stainless steel and plastic particles.
10 products
Horizon Organic recalls Chocolate Lowfat Milk 8-oz boxes due to package integrity issues.

...And Kimchi kimchi recalled for undeclared fish allergen.

Fresenius recalls DELFLEX dialysis solution due to potential bag leaks compromising sterility.
2 products
Ajanta recalls Duloxetine 30 mg capsules over nitrosamine impurity above FDA limit.
3 products
Sungal Inc. recalls XZL Jelly Snacks 12.68 oz bags due to undeclared FD&C Yellow #5, #6, and Red #40.

Montebianco Base Vegan is recalled due to undeclared milk, which exceeds acceptable levels despite the product's warning label.

Physio-Control is recalling various LIFEPAK defibrillators serviced without proper performance inspections, potentially delaying therapy.

Second Nature recalls Keto Crunch Smart Mix 10 oz pouches due to undeclared cashews, pistachios, and dried cherries.

Spacelabs is recalling the Ultraview SL Command Module due to a manufacturing issue with the electrical leakage tester.
2 products
Centinel Spine recalls Prodisc C SK cervical disc implants due to labeling mix-up (5mm/6mm).
2 products
Boston Scientific recalls LUX-DX II Arrhythmia Detector (M302) with LATITUDE DRAGON US Server (6460) over missing PVC Burden and Bradyarrhythmia monitoring.
2 products
Erbe Medical recalls ERBEFLO CleverCap CO2 tubing/cap sets due to risk of water aspiration and respiratory failure.
3 productsIntuitive Surgical is recalling the USM arm sub-assembly for da Vinci X and Xi systems due to a risk of internal screw breakage.
2 products
My Mochi Strawberry Non-Dairy Frozen Dessert recalled due to foreign object in container.

Calypso Tropic Tango Lemonade recalled for undeclared Yellow No. 5.

Ganesha Enterprises is recalling KLG Kesar Mukhwas (200 gm) for undeclared food colorings and unapproved dye.

Medline recalls kits with Webcol Alcohol Prep Pads due to possible non-sterility and contamination risk.
10 products
Medline recalls Neuro Sponges (8 sizes) over elevated endotoxin levels.
38 products
Hikma is recalling Alendronate Sodium Oral Solution 70 mg/75 mL (NDC 0054-0282-59) due to out-of-specification assay results.

Immuno-Mycologics is recalling Myco DDR Trident Neutralization Buffer B due to potential contamination.

Depuy Synthes recalls ATTUNE Revision Hinge Femoral over packaging adhesion that may compromise sterility.
9 products
Siemens is recalling epoc BGEM BUN Test Cards due to inaccurate pH and mTCO2 results that could lead to improper patient treatment.

Straumann recalls n!ce PMMA Full-arch Restoration due to incorrect screw seat interface.
2 products
BD recalls GasPak EZ CO2 and Campy pouch systems over low CO2 output.
2 products
Merit Medical recalls Philips Bridge Prep Kit (REF K12-09098B) over catheter resistance on guidewire.
4 products
Abbott recalls i-STAT EG7+ cartridges (03P76-25) over inaccurate PCO2/pH results.
3 products
Elekta is recalling the Leksell Vantage Arc System due to a risk of coordinate shifting caused by faulty locking mechanisms.

Beta Bionics is recalling iLet Bionic Pancreas (software 1.4.2–1.4.3) for Dexcom G7 compatibility issues that may disable glucose correction dosing.

Scope Health is recalling Optase Dry Eye Intense Drops (0.33 fl oz, NDC 72972-002-01) due to lack of assurance of sterility.

Thea Pharma recalls iVIZIA Sterile Lubricant Eye Drops (Povidone 0.5%) over sterility concerns from CGMP deviations.
2 products
Hadson is recalling Negita Cracker Shrimp 2.8 oz over undeclared FD&C Yellow 6.

Lactalis recalls Specially Selected Vanilla Creme Brulee over possible glass fragments.

Wells Pharma recalls injectable drugs (phenylephrine, fentanyl, ketamine) over cGMP deviations.
7 products