Archive
1,113 recalls were announced in May 2018.
Of the 1,113 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.
Which agencies issued them
Milbar Laboratories is recalling 4,815 tubes of Naturmetic SPF 50 Sunscreen due to Good Manufacturing Practice (GMP) deviations.
ConvaTec is recalling 200 boxes of Esteem Synergy Stomahesive skin barriers because the stoma hole is larger than the 22mm size specified on the label.
Ethicon Endo-Surgery Inc is recalling 5mm Endopath Xcel trocars due to insufficient lubrication, which may prolong surgery or introduce minute particles.
Mylan Pharmaceuticals is recalling specific lots of Amlodipine and Benazapril HCL Capsules because the cleaning process for manufacturing equipment was not followed according to procedure.
Prescript Pharmaceuticals is recalling Clindamycin 300 mg capsules because the storage temperature label differs from the manufacturer's original declaration.
Prescript Pharmaceuticals is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because the storage temperature instructions on the label differ from the original manufacturer's declaration.
Perrigo New York is recalling 571,632 tubes of Hydrocortisone Ointment 2.5% because the product failed stability specifications.
Milbar Laboratories is voluntarily recalling 14,491 tubes of MD Complete Clarifying Cleanser due to Good Manufacturing Practice (GMP) deviations.
Sun Pharmaceutical Industries is recalling one lot of Sulfamethoxazole and Trimethoprim tablets because polyethylene was detected in two tablets.
Beckman Coulter is recalling 523 boxes of MicroScan MICroSTREP Plus Panel and associated broth due to quality control testing failures.
Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or risk introducing minute particles.
Bard Peripheral Vascular Inc is recalling 140 units of the Seeker Crossing Support Catheter due to potential bacterial endotoxin on packaging hoops.
CooperSurgical is recalling 500 units of the Fischer Cone Biopsy Excisor, Medium, because the products were packaged with an incorrect product size.
Prescript Pharmaceuticals is recalling Chlorhexidine 0.12% liquid due to a storage temperature labeling discrepancy. The product was distributed in California.
Volcano Corporation is recalling eight Philips Volcano CORE M2 Vascular Systems because an incorrect resistor causes noise and overly bright images.
Ethicon Endo-Surgery is recalling 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.
Mylan Pharmaceuticals is recalling Amlodipine and Benazapril HCL Capsules because cleaning processes for manufacturing equipment were not followed according to procedure.
Ethicon Endo-Surgery is recalling 1,500 units of 5mm Endopath Xcel trocars because insufficient lubrication may prolong surgery or introduce minute particles.
Rockwell Medical is recalling DriSate hemodialysis acid concentrate because a subassembly component contained small amounts of sodium bicarbonate from a prior batch.
Milbar Laboratories is recalling 2,156 tubes of Solar Defense Sheer Sunscreen SPF50 due to Good Manufacturing Practice (GMP) deviations.
L. Perrigo is recalling 569,520 cartons of Scopolamine Transdermal System nationwide due to a defective delivery system.
Boiron Inc. is recalling 52,810 tubes of Calendula Cream because the outer carton incorrectly lists the active ingredient concentration as 7% instead of 10%.
Epic Extremity, LLC is recalling 9 units of the 10x10 Plate Caddy due to an artwork error that misidentifies a specific plate and screw.
Sun Pharmaceutical Industries is recalling Riomet (metformin hydrochloride) oral solution due to identified labeling discrepancies in the patient literature.
Uno Foods Inc. is recalling 1,881 pounds of ham and cheese calzones because the packages contain buffalo chicken calzones instead.
Epic Extremity, LLC is recalling 6 units of the Epic Extremity Plate System due to a packaging error that misidentifies a specific plate and screw.
Coltene Whaledent Inc is recalling 11 packs of Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack carbide burs because they are labeled with an incorrect product number.
Aidarex Pharmaceuticals LLC is recalling 450 bottles of Ferrous Sulfate 325 MG tablets distributed in Florida because foreign tablets or capsules were found in the product.
Columbia Northwest is recalling 2016-2017 Somerset Newport and Chesapeake trailers because a front weld may fail, causing the trailer to drop and increasing crash risk.
Daimler Vans USA is recalling 2015-2017 Mercedes-Benz Metris vehicles because improperly tightened transmission support bolts may damage the driveshaft, increasing crash risk.
Fuel Helmets is recalling specific Open Face helmets that may not adequately protect the wearer's head in an impact, increasing the risk of injury.
Porsche is recalling My First Porsche wooden toy cars because wheels and axles can detach, posing a choking hazard to young children.
Forest River is recalling 2019 Coachmen Clipper and Viking trailers because the Federal Placard lists incorrect tire pressure, which could lead to underinflation and tire failure.
Van-Con is recalling one 2016 33803 Dual Rear Wheel school bus because roof panel seams were not correctly bonded, posing an increased injury risk in a crash.
Hempler Foods Group is recalling ready-to-eat pepperoni sticks because they contain milk, a known allergen, that is not declared on the label.
Setra is recalling 2017-2018 S417 TC and S407 CC motorcoaches because a steering drop arm nut may loosen, potentially causing a loss of steering control.
LuK is recalling hybrid propulsion systems where oil accumulation may cause an electrical short and increase fire risk. Dealers will inspect and replace components free of charge.
Chrysler is recalling over 4.8 million vehicles because a wiring short may prevent the cruise control system from disengaging, increasing crash risk.
Tiffin is recalling 2013-2018 Allegro Open Road motorhomes because weak frame rails may allow the tow hitch to detach, increasing crash risk.
Daimler Trucks North America is recalling 2003-2006 Thomas Built Buses Minotour transit buses because a missing relay may allow the wheelchair lift to operate while the vehicle is moving, increasing injury risk.
Suzuki is recalling 2013 Kizashi and SX4 vehicles with CVT transmissions because the Transmission Control Module may fail, causing reduced speed or acceleration.
Michaels is recalling Creatology pottery wheel kits because the battery compartment can overheat, posing fire and burn hazards. No injuries have been reported.
Michaels is recalling Creatology Spin Art Kits because the battery compartment can overheat, posing fire and burn hazards. No injuries have been reported.
Rebel West Powersports is recalling one 2018 Rebel R4 LSV because it lacks required rear side reflex reflectors, which reduces visibility to other drivers.
Discount School Supply is recalling Colorations brand extra-large crayons because red crayons may contain glass, posing a laceration hazard.
Triangle Pharmanaturals LLC is recalling Lifted Kratom Green Maeng Da products due to potential Salmonella contamination.
Triangle Pharmanaturals LLC is recalling Molecule Kratom Gold Bali products because they may be contaminated with Salmonella.
Triangle Pharmanaturals LLC is recalling Naturally Kratom Green Malay capsules due to potential Salmonella contamination. The product was distributed in 24 states.
Labrada Nutrition is recalling 132 units of Lean Pro 8 Cookies & Cream protein powder due to undeclared egg. The product was distributed in the US and internationally.
Triangle Pharmanaturals LLC is recalling all Kratom products due to potential Salmonella contamination. The recall covers Raw Form Organics Maeng Da Kratom Ruby Red capsules.
Triangle Pharmanaturals LLC is recalling Molecule Kratom Super Green Malay products because they may be contaminated with Salmonella.
Triangle Pharmanaturals LLC is recalling Molecule Kratom Green Maeng Da products due to potential Salmonella contamination. The recall covers multiple package sizes distributed across 24 states.
Triangle Pharmanaturals LLC is recalling Chameleon Kratom Formula 51 capsules because all Kratom products from the firm may be contaminated with Salmonella.
Maya Distribution, LLC is recalling Dragon Malaysian Kratom products because samples tested positive for Salmonella. The products were distributed to retail stores in eight states.
Eden's Ethnos LLC is recalling 2,775 kilograms of bulk Kratom powder because FDA and state samples found Salmonella. The product was distributed in five states.
Triangle Pharmanaturals LLC is recalling Molecule Kratom Red Maeng Da products due to potential Salmonella contamination.
Triangle Pharmanaturals LLC is recalling Third Eye Kratom Red capsules because all Kratom products from the company may be contaminated with Salmonella.
Badger Botanicals LLC is recalling specific Kratom products due to potential Salmonella contamination. Consumers should stop using these items.
Triangle Pharmanaturals LLC is recalling Third Eye Kratom Bali capsules because all Kratom products from the firm may be contaminated with Salmonella.
Triangle Pharmanaturals LLC is recalling Molecule Kratom Red Malay products due to potential Salmonella contamination. The products were distributed in 24 states.
Badger Botanicals LLC is recalling specific Kratom products due to potential Salmonella contamination.
Triangle Pharmanaturals LLC is recalling Chameleon Kratom Formula 27 capsules due to potential Salmonella contamination. The product was distributed in 24 states.
Greenbelt Greenhouse Ltd is recalling Spicy Microgreen Mix due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.
Triangle Pharmanaturals LLC is recalling Molecule Kratom White Maeng Da products in various formats due to potential Salmonella contamination.
Maya Distribution, LLC is recalling Dragon Ultra Enhanced Indo Extract capsules because samples tested positive for Salmonella.
Maya Distribution, LLC is recalling Dragon Maeng Da Kratom Powder and capsules because samples tested positive for Salmonella. The product was sold in eight states.
Triangle Pharmanaturals LLC is recalling Naturally Kratom Red Malay capsules because all Kratom products from the firm may be contaminated with Salmonella.
Triangle Pharmanaturals LLC is recalling Lifted Kratom White Maeng Da products due to potential Salmonella contamination. The recall covers powder and capsule bottles distributed in 24 states.
Triangle Pharmanaturals LLC is recalling Live Well Kratom Green Maeng Da capsules in 150 and 300-count bottles due to potential Salmonella contamination.
Triangle Pharmanaturals LLC is recalling Molecule Kratom White Borneo products in various formats due to potential Salmonella contamination.
Badger Botanicals LLC is recalling specific Kratom products due to potential Salmonella contamination.
Eastland Food Corporation is recalling Asian Best Tamarind Candy due to lead levels exceeding FDA action limits.
Datascope is recalling 18 custom tubing kits because a seal defect may cause balloon collapse, increasing resistance to flow in the venous line.
Datascope Corporation is recalling the Better Bladder device found in custom tubing kits. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.
Labrada Nutrition is recalling specific lots of Lean Pro 8 Vanilla protein powder due to undeclared egg, a major food allergen.
Continental Tire is recalling specific Conti Hybrid HS3 tires because visible cords may cause sudden air loss, increasing the risk of a crash.
Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may allow air to enter the housing, potentially causing a drop in ECMO circuit blood flow.
Grato Holdings is recalling Energique herbal supplements because they are marketed as unapproved new drugs based on disease claims.
Vitalab Pharmacy is recalling Alprostadil 20 mcg/mL injectable vials because airflow patterns may not support aseptic production, raising sterility concerns.
Kroger Specialty Pharmacy is recalling Azithromycin 250 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Polaris is recalling 2017-2018 Slingshot models because brake pedals may separate from the master cylinder, causing loss of braking ability.
Vitalab Pharmacy is recalling 22 vials of a sterile injectable drug because airflow patterns may not support aseptic production, raising sterility concerns.
Vitalab Pharmacy, Inc. is recalling a sterile injectable drug product because airflow patterns may not support aseptic production, raising sterility concerns.
Triangle Pharmanaturals LLC is recalling Lifted Kratom Red Maeng Da products due to potential Salmonella contamination. The recall covers powder and capsule bottles distributed across multiple states.
Kroger Specialty Pharmacy is recalling Capecitabine 500 mg tablets due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Triangle Pharmanaturals LLC is recalling Naturally Kratom White Maeng Da capsules due to potential Salmonella contamination.
Grato Holdings is recalling Peaceful Mountain Stomach Rescue dietary supplements because they are unapproved new drugs based on disease claims.
McNeilus is recalling 2008-2018 Bridgemaster V concrete mixers because a hydraulic tank may overpressurize and rupture, posing risks of injury and road hazards.
Kroger Specialty Pharmacy is recalling Temozolomide 20 mg capsules because of a lack of processing controls. The affected products were dispensed in five states.
Datascope Corporation is recalling specific custom tubing kits because a seal defect may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.
Kroger Specialty Pharmacy is recalling Albuterol 0.083% Inhalation Solution due to a lack of processing controls. The affected lots were dispensed in five states between December 2017 and February 2018.
Volkswagen is recalling 2018 Tiguan vehicles because a loose front ball joint nut may cause steering or stability issues, increasing crash risk.
Datascope is recalling 18 custom tubing kits because a seal defect may allow air to enter the device, potentially causing a drop in ECMO blood flow.
Datascope Corporation is recalling Better Bladder custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.
Vitalab Pharmacy is recalling specific lots of sterile injectable drugs because airflow patterns may not support aseptic production, raising sterility concerns.
BMW of North America is recalling certain 2018 BMW M5 vehicles because engine control unit software may cause the fuel pump to stop, increasing crash risk.
Vitalab Pharmacy is recalling 178 vials of Methylcobalamin for injection because airflow patterns may not support aseptic production, raising sterility concerns.
Coast Quality Pharmacy LLC is recalling 52 vials of Macroaggregated albumin (MAA) kits due to a lack of assurance of sterility. The affected products were distributed to six states.
Labrada Nutrition is recalling specific lots of Lean Pro 8 Chocolate protein powder due to undeclared egg, a major food allergen.
AuroMedics Pharma LLC is recalling 54,720 vials of Ampicillin and Sulbactam for Injection due to confirmed reports of visible red rubber particles.
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