Recall: Infants’ Ibuprofen Concentrated Oral Suspension by: Tris Pharma
FDA issued recall of infants’ ibuprofen concentrated oral suspension (50 mg per 1.25 mL) by Tris Pharma due to incorrect concentrations.... Read More
Pharmacy Services Recalls
2018 Recalls
Recall: Spinal Fusion and Long Bone Stimulators by Zimmer Biomet
FDA issued recall of spinal fusion and long bone stimulators by Zimmer Biomet due to manufacturing issues.... Read More
Recall: BrightMatter Guide with SurfaceTrace Registration by Synaptive Medical
FDA issued recall of BrightMatter Guide with SurfaceTrace Registration by Synaptive Medical due to software defect.... Read More
Recall: Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets by Teva Pharmaceuticals USA
FDA issued recall of all amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets by Teva Pharmaceuticals USA due to an impurity.... Read More
Recall: ThermaCare HeatWraps by Pfizer
FDA issued recall of six lots of ThermaCare HeatWraps by Pfizer due to skin injury potential.... Read More
Recall: EPICS by Beckman Coulter Life Sciences
FDA issued recall of FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) by Beckman Coulter Life Sciences due to product failure.... Read More
Recall: Sodium Chloride Injection, USP, 0.9% by Fresenius Kabi
FDA issued recall of Sodium Chloride Injection, USP, 0.9% by Fresenius Kabi due to incorrect product labeling.... Read More
Recall: TB Temporary Bipolar Pacing Leads by Oscor
FDA issued recall of TB Temporary Bipolar Pacing Leads by Oscor due to connector separation.... Read More
Recall: EPICS XL Series Flow Cytometers by Beckman Coulter Life Sciences
FDA issued recall of EPICS XL Series flow cytometers by Beckman Coulter Life Sciences due to inaccurate results.... Read More
Recall: Valsartan-containing products by Mylan
FDA issued recall of valsartan-containing products by Mylan due to trace amounts of N-nitrosodiethylamine.... Read More
Recall: TB Unshrouded Bipolar Pacing Lead by Oscor
FDA issued recall of TB Unshrouded Bipolar Pacing Lead by Oscor due to possible connector cap movement and connection wire exposure.... Read More
Recall: Millennium Nuclear Medicine Systems by GE Healthcare
FDA issued recall of Millennium Nuclear Medicine Systems by GE Healthcare due to risk of detector detaching and falling.... Read More
Recall: Losartan Potassium and Hydrochlorothiazide by Sandoz
FDA issued recall of losartan potassium and hydrochlorothiazide by Sandoz due to trace amounts of NDEA (N-Nitrosodiethylamine).... Read More
Recall: Puriton Eye Relief Drops by Kadesh Incorporation
FDA issued recall of Puriton Eye Relief Drops by Kadesh Incorporation due to non-sterile production conditions.... Read More
Recall: CoaguChek XS PT Test Strips by Roche Diagnostics
FDA issued recall of CoaguChek XS PT Test Strips by Roche Diagnostics due to inaccurate INR test results.... Read More
Recall: Irbesartan Tablets by Sciegen Pharmaceuticals
FDA issued recall of irbesartan tablets by Sciegen Pharmaceuticals due to detection of trace amounts of NDEA (N-Nitrosodiethylamine).... Read More
Recall: Prednisolone and Gatifloxacin Ophthalmic Solution
FDA issued recall of prednisolone and gatifloxacin ophthalmic solution 1%/0.5% sterile, 3 mL vials by Promise Pharmacy due to small particulate floating in the solution.... Read More
Recall: Zero Xtreme by Fat Burners Zone
FDA issued recall of Zero Xtreme by Fat Burners Zone due to presence of undeclared sibutramine.... Read More
Recall: AFX Endovascular AAA Systems by Endologix
FDA issued recall of AFX Endovascular AAA Systems by Endologix due to risk of type III endoleaks .... Read More
Recall: Regen Series Product by Liveyon
FDA issued recall of Regen Series product by Liveyon (manufactured by Genetech, Inc.) due to reported possible adverse reactions.... Read More
Recall: Homeopathic Aqueous-Based Medicines by Eight and Company LLC (Sprayolog)
FDA issued recall of homeopathic aqueous-based medicines by Eight and Company, d/b/a Sprayolog due to microbial contamination.... Read More
Recall: Human and Animal Drug Products by Silver Star Brands
FDA issued recall of human and animal drug products by Silver Star Brands due to microbial contamination.... Read More
Voluntary Nationwide Recall: Robaxin® 750mg Tablets by Endo Pharmaceuticals
Endo Pharmaceuticals issues voluntary nationwide recall of two lots of Robaxin® 750mg tablets 100 count bottle packs due to incorrect daily dosing information on label.... Read More
Voluntary Nationwide Recall: NeoRelief for Muscle Cramping and Restlessness by BioLyte Laboratories
BioLyte Laboratories issues voluntary nationwide recall of NeoRelief for muscle cramping and restlessness topical gel due to possible microbial contamination.... Read More
Voluntary Nationwide Recall: All Sterile Compounded Drugs by Pharm D Solutions, LLC
Pharm D Solutions, LLC issues voluntary nationwide recall of all sterile compounded drugs due to potential lack of sterility assurance.... Read More
Recall: Homeopathic Aqueous/Alcohol-Based Medicines by Beaumont Bio Med
FDA issued recall of homeopathic aqueous/alcohol-based medicines by Beaumont Bio Med due to possible microbial contamination.... Read More
Recall: Tri-Flo Subglottic Suction System by Vyaire Medical
FDA issued recall of Tri-Flo Subglottic Suction System by Vyaire Medical due to risk of device breakage.... Read More
Voluntary Withdrawal: CyPass Micro-Stent by Alcon
Alcon issues voluntary global withdrawal of CyPass Micro-Stent for surgical glaucoma due to statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone.... Read More
Recall: CPAP Mask Cushion Devices by Compass Health Brands
Compass Health Brands recall of CPAP mask cushion devices due to possible air leaks.... Read More
Neuroveen, Respitrol, Thyroveev, and Compulsin by Hellolife, Inc.
Hellolife, Inc. issues voluntary nationwide recall of Neuroveen, Respitrol, Thyroveev, and Compulsin due to possible microbial contamination.... Read More
Recall: Nasal Products and Baby Oral Gels by Product Quest Manufacturing
FDA issued recall of nasal products and baby oral gels by Quest Manufacturing due to possible microbial contamination.... Read More
Recall: Children’s Advil by Pfizer
FDA issued recall of Children’s Advil by Pfizer Lot# R51129 due to dosage cup mislabeling.... Read More
Recall: Hydrochlorothiazide Tablets USP 12.5 Mg by Accord Healthcare
FDA issued recall of Hydrochlorothiazide Tablets USP 12.5 Mg by Accord Healthcare due to labeling mix-up.... Read More
Recall: Weight Away Remedy by Living Well Remedies
FDA issued recall of Weight Away Remedy by Living Well Remedies due to microbial contamination.... Read More
Recall: Leukotrap RC System with RC2D Filter by Haemonetics Manufacturing
FDA issued recall of Leukotrap RC System with RC2D filter by Haemonetics Manufacturing due to reports of higher than expected residual WBC.... Read More
Recall: Antimicrobial Susceptibility Testing Cards by BioMerieux
FDA issued recall of VITEK 2 Gram Positive antimicrobial susceptibility testing cards by BioMerieux due to False Results for some strains of methicillin-resistant Staphylococcus aureus.... Read More
Voluntary Recall: King Bio Kids and Infant Products
King Bio issues voluntary nationwide recall of kids and infant products due to potential microbial contamination.... Read More
Recall: Porcine Thyroid API from Sichuan Friendly Pharmaceutical Co
FDA issued recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co due to inconsistent potency in the active ingredient.... Read More
Recall: World Organix, LLC Blissful Remedies
World Organix, LLC issues voluntary nationwide recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, and Blissful Remedies 4 Hour Chill Slow Motion Blend due to high microbial loads contamination.... Read More
Recall: Levothyroxine and Liothyronine (Thyroid Tablets, USP)
Westminster Pharmaceuticals, LLC. issues voluntary nationwide recall of levothyroxine and liothyronine (Thyroid Tablets, USP) due to risk of adulteration.... Read More
Recall: Camber Pharmaceuticals Valsartan Tablets
Camber Pharmaceuticals, Inc. issues voluntary nationwide recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg due to detection of trace amounts of N-Nitrosodimethylamine (NDMA) impurity, found in an active pharmaceutical ingredient.... Read More
Recall: Arkon Anesthesia Delivery System
FDA issued recall of Arkon Anesthesia Delivery System due to unexpected failed state while in use or idle.... Read More
Recall: AirLife Resuscitation Devices by Vyaire Medical
FDA issued recall of AirLife Resuscitation Devices by Vyaire Medical due to manufacturing error preventing oxygen delivery.... Read More
Recall: Quest Manufacturing LLC CVS Health 12 Hour Sinus Relief Nasal Mist
Quest Manufacturing LLC issues voluntary nationwide recall of CVS Health 12 Hour Sinus Relief Nasal Mist due to microbiological contamination.... Read More
Recall: Qiagen Sciences LLC AmniSure ROM Test
FDA issued recall of Qiagen Sciences LLC AmniSure ROM Test due to lack of control line, which may lead to misinterpretation of test results.... Read More
Recall: Piperacillin and Tazobactam by AuroMedics Pharma
Voluntary nationwide recall of piperacillin and tazobactam for injection 3.375 grams per vial by AuroMedics Pharma due to presence of particulates identified as glass and silicone.... Read More
Recall: Ranier’s Rx Laboratory
Ranier’s Rx Laboratory issues voluntary recall of all sterile compounded products within expiry due to lack of sterility concerns.... Read More
Recall: King Bio
FDA issued recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids by King Bio due to microbial contamination.... Read More
Recall: valsartan
FDA issued recall of several drug products containing the active ingredient valsartan due to detection of an impurity.... Read More
Recall: Saje Splish Splash Gentle Baby Wash
FDA issued recall on Saje Splish Splash Gentle Baby Wash due to pseudomonas aeruginosa bacteria.... Read More
Recall: Monsel’s Solution by MedGyn Products
FDA issued recall on Monsel’s Solution by MedGyn Products due to possible contamination or decreased quality.... Read More
Recall: Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105
FDA issued recall on Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 due to misinterpretation of display messages for out of range values.... Read More
Recall: Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical
FDA issued recall on Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical due potential salmonella contamination.... Read More
Recall: CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.
FDA issued recall on CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp. due to fluid ingress that may affect device operation and interrupt or delay therapy.... Read More
Recall: Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira
FDA issued recall on naloxone hydrochloride injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira due to the potential presence of particulate matter.... Read More
Recall: HeartWare HVAD System by Medtronic
FDA issued recall on HeartWare HVAD system by Medtronic due to unintended intermittent electrical disconnection between the power source and the controller.... Read More
Recall: STAT-Check and Medline Manual Resuscitator Bags by SunMed Holdings
FDA issued recall on STAT-Check and Medline manual resuscitator bags by SunMed Holdings due to patient port may detach during use.... Read More
Recall: Fluticasone Propionate Nasal Spray by Apotex Corp
FDA issued recall on Fluticasone propionate nasal spray by Apotex Corp due to potential for small glass particles.... Read More
Recall: TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan
FDA issued recall on TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan due to out of sequence capsules.... Read More
Recall: X-Jow and Acne Shave Products by Shadow Holdings
FDA issued recall on X-Jow and Acne Shave products by Shadow Holdings due to possible bacterial contamination.... Read More
Recall: 95% Ethyl Alcohol Product by Ethanol Extraction
FDA issued recall on 95% ethyl alcohol product by Ethanol Extraction due to a possible contamination with methanol.... Read More
Recall: HeartMate 3™ Left Ventricular Assist System
FDA issued recall on HeartMate 3™ Left Ventricular Assist System due to potential malfunction that may lead to graft occlusion.... Read More
Recall: Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing
FDA issued recall on homeopathic teething drops, nausea drops, intestinal colic drops, stomach calm, expectorant cough syrup, silver-zinc throat spray, and argentum elixir by MBI Distributing due to a lack of adequate controls.... Read More
Recall: 7K and Poseidon 4500 by Shoreside Enterprises
FDA issued recall on 7K and Poseidon 4500 by Shoreside Enterprises due to presence of undeclared sildenafil and/or tadalafil.... Read More
Recall: MindFrame Capture LP Revascularization Device by Medtronic
FDA issued recall on MindFrame Capture LP Revascularization Device by Medtronic due to wire material that may break or separate during use.... Read More
Recall: Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical
FDA issued recall on Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical due to risk of malfunction caused by error in product design.... Read More
Recall: Fabius Anesthesia Machines by Dräger Medical
FDA issued recall on Fabius Anesthesia Machines by Dräger Medical due to production step error.... Read More
Recall: Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma
FDA issued recall on ampicillin and sulbactam for injection USP, 3 g single-dose vials by AuroMedics Pharma due to red particulate matter.... Read More
Recall: Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma
FDA issued recall on piperacillin and tazobactam for injection, USP 3.375 g vials by AuroMedics Pharma due to particulate matter.... Read More
Recall: NxtGen Botanicals Maeng Da Kratom by NGB Corp.
FDA issued recall on NxtGen Botanicals Maeng Da Kratom by NGB Corp. due to possible salmonella contamination.... Read More
Recall: Certain Kratom-Containing Powder Products by Viable Solutions
FDA issued recall on certain kratom-containing powder products by Viable Solutions due to possible salmonella contamination.... Read More
Recall: All Products Marketed as Sterile by Coastal Meds
FDA issued recall on all products marketed as sterile by Coastal Meds due to visible particles in some of the drug vials for injection.... Read More
Recall: Acrodose PLus and PL Systems by Haemonetics
FDA issued recall on Acrodose PLus and PL systems by Haemonetics due to low pH readings for platelets stored in CLX HP Bag.... Read More
Recall: Sterile Injectable Products by Premier Pharmacy Labs
FDA issued recall on sterile injectable products by Premier Pharmacy Labs due to lack of sterility assurance.... Read More
Recall: Maeng Da Red Powder and Capsules by Club 13
FDA issued recall on Maeng Da Red powder and capsules by Club 13 due to possible contamination with salmonella.... Read More
Recall: Kratom-containing Products by Triangle Pharmanaturals
FDA issued recall on kratom-containing products by Triangle Pharmanaturals due to risk of salmonella.... Read More
Recall: Dietary Supplements by Nutrizone
FDA issued recall on Dietary supplements by Nutrizone due to potential for salmonella contamination.... Read More
Recall: Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA
FDA issued recall on Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA due to possible potential contamination.... Read More
Recall: Eclipse Kratom by Tamarack
FDA issued recall on Eclipse Kratom by Tamarack due to possible salmonella contamination.... Read More
Recall: BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD)
FDA issued recall on BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD) due to chemical interference with certain tests.... Read More
Recall: NeuroBlate Probe by Monteris Medical
FDA issued recall on NeuroBlate Probe by Monteris Medical due to unintended heating.... Read More
Recall: Alka-Seltzer Plus Products
FDA issued recall on Alka-Seltzer Plus products because ingredients on front sticker may not match product in carton.... Read More
Recall: Kratom-containing Powder Products by PDX Aromatics
FDA issued recall on kratom-containing powder products by PDX Aromatics due to potential for contamination with salmonella.... Read More
Recall: Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals
FDA issued recall on methylprednisolone sodium succinate for injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals due to high out of specification impurity results.... Read More
Recall: Hydromorphone HCL Injection USP by Hospira
FDA issued recall on hydromorphone hcl injection USP by Hospira due to potential for empty or cracked glass vials.... Read More
Recall: Bella Diet Capsules by Bella All Natural
FDA issued recall on Bella Diet Capsules by Bella All Natural due to presence of sibutramine.... Read More
Recall: Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic
FDA issued recall on Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic because manufacturing error preventing electrical shock delivery.... Read More
Recall: Labetalol Hydrochloride Injection by Hospira
FDA issued recall on labetalol hydrochloride Injection by Hospira due to potential for cracked glass at rim surface of vials.... Read More
Recall: Acyclovir 400mg Tablets by Apace Packaging
FDA issued recall on Acyclovir 400 mg Tablets by Apace Packaging due to product mix-up.... Read More
Recall: HeartStart MRx Defibrillator by Philips Electronics
FDA issued recall on HeartStart MRx Defibrillator by Philips Electronics because defects in gas discharge tubes may cause device failure.... Read More
Recall: Gericare Eye Wash by Kareway Products
FDA issued recall on Gericare Eye Wash by Kareway Products due to potential product contamination.... Read More
Recall: AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical
FDA issued recall on AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical due to manufacturing error.... Read More
Recall: Multiple Drug Products by Flawless Beauty
FDA issued recall on multiple drug products by Flawless Beauty because they are misbranded or unapproved.... Read More
Recall: Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories
FDA issued recall on Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories due mislabeling.... Read More
Recall: Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics
FDA issued recall on Levofloxacin in 5 percent dextrose 250mg/50mL by AuroMedics due to presence of visible particulate matter.... Read More
Recall: Certitude Delivery System by Edwards Lifesciences
FDA issued recall on Certitude Delivery System by Edwards Lifesciences due to mold overflow defect which may obstruct blood flow.... Read More
Recall: Clopidogrel Tablets USP, 75 mg by International Laboratories
FDA issued recall on Clopidogrel tablets USP, 75 mg by International Laboratories due to product mislabeling.... Read More
Recall: Compounded Sterile Products by PharMEDium Services
FDA issued recall on ampicillin and sulbactam for injection USP 1.5 g/vial by Auromedics due to presence of glass particles in vial.... Read More
Recall: Compounded Sterile Products by PharMEDium Services
FDA issued recall on compounded sterile products by PharMEDium Services due to lack of sterility assurance.... Read More
Recall: Reprocessed Agilis Steerable Introducer Sheath by Sterilmed
FDA issued recall on reprocessed Agilis Steerable introducer sheath by Sterilmed due to improper seal of sheath hub.... Read More