Product Recall Lookup
Check whether a product was recalled by name or manufacturer. These are official U.S. FDA food, drug, and device recalls, presented as-is — the FDA makes the determination. No install, no login, no personal data.
118 results
- Food Class I · high risk
Grade A White In-shell Chicken eggs packaged in the following configurations: 1. Kroger, Medium, 12 Eggs, Net…
MIDWEST POULTRY SERVC C/O H & LELECTRIC — Possible Salmonella Enteritidis
- Food Class I · high risk
Dark Chocolate Coconut Almond Bites, 3.17oz, Plastic Pouches, 10 Packages per case.
Bazzini LLC — Undeclared peanuts
- Food Class III · low
Honeyville YELLOW COLOR 1 GALLON NFI: WATER, FD&C YELLOW #5, FD&C YELLOW #6, CITRIC ACID, AND SODIUM BENZOATE…
FlavorsandColor.Com — Undeclared Red #40.
- Food Class II · moderate
Vodka Tomato Sauce, NET WT. 24 oz / 680g, glass jar packed 12 jars in a carton.
SHEANDRO LLC — Label declares cream and cheese, but Milk is not declared
- Food Class I · high risk
Grade A Brown In-shell Chicken eggs packaged in the following configurations: 1. Simple Truth, Natural Cage F…
MIDWEST POULTRY SERVC C/O H & LELECTRIC — Possible Salmonella Enteritidis
- Drug Class I · high risk
Kian Pee Wan Capsules, 30-count bottles
Buy-Herbal — Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredi…
- Drug Class II · moderate
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pha…
Shoolin Pharma Chem LLP — CGMP Deviations:Noted during FDA inspection
- Drug Class II · moderate
SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneou…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class I · high risk
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Al…
Victory Medical Center Pharmacy — Microbial Contamination of Sterile Products - out of specifications results wer…
- Drug Class II · moderate
SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class II · moderate
SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APO…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class I · high risk
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple…
Liebel-Flarsheim Company LLC — Presence of Particulate Matter: comprising polyethylene and other plastic mater…
- Drug Class II · moderate
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet…
Heritage Pharmaceuticals Inc — Presence of Foreign Substance: presence of particles and white flakes in the re…
- Drug Class II · moderate
SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneo…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class II · moderate
SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APO…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class II · moderate
SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class II · moderate
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products…
Prestige Brands Holdings — Lack of assurance of sterility. The recall is due to potential contamination
- Drug Class II · moderate
SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous In…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class II · moderate
SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous In…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class II · moderate
SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO c…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class II · moderate
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem …
Shoolin Pharma Chem LLP — CGMP Deviations:Noted during FDA inspection
- Drug Class II · moderate
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Che…
Shoolin Pharma Chem LLP — CGMP Deviations:Noted during FDA inspection
- Drug Class II · moderate
SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class II · moderate
Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenvil…
Novartis Pharmaceuticals Corporation — Failed Dissolution Specifications
- Drug Class II · moderate
SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Inj…
Apollo Care, LLC — Presence of Particulate Matter; identified as a nylon/polyamide and silk/protei…
- Drug Class II · moderate
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Phar…
Shoolin Pharma Chem LLP — CGMP Deviations:Noted during FDA inspection
- Drug Class II · moderate
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LL…
Shoolin Pharma Chem LLP — CGMP Deviations:Noted during FDA inspection
- Device Class II · moderate
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expanding endoprosthesis d…
W L Gore & Associates, Inc. — 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly la…
- Device Class II · moderate
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SP…
Cardinal Health 200, LLC — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled d…
- Device Class II · moderate
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V…
Covidien, LP — Product may contain a perforation or tear in the sterile barrier packaging. Thi…
- Device Class II · moderate
BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in f…
MICROVENTION INC. — Due to an increase rate of balloon pinhole defects.
- Device Class II · moderate
Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC
Cardinal Health 200, LLC — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled d…
- Device Class II · moderate
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Number MSC351450BG4
Medline Industries, LP — Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bl…
- Device Class II · moderate
Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , …
Cardinal Health 200, LLC — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled d…
- Device Class II · moderate
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Firmware issue potentially leading to loss of geometry movements.
- Device Class II · moderate
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is …
Terumo Medical Corporation — Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
- Device Class II · moderate
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number MSC351450AN
Medline Industries, LP — Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bl…
- Device Class II · moderate
Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number MSC351410AN
Medline Industries, LP — Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bl…
- Device Class I · high risk
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule M…
Spectra Medical Devices, Llc — Manufacturing firm, Huons, was cited for issues regarding product quality and s…
- Device Class I · high risk
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Baxter Healthcare Corporation — Baxter received customer reports of air bubbles in the drip chamber and tubing …
- Device Class II · moderate
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dila…
Galt Medical Corporation — Black depth markings may detach from the outer sheath of the coaxial dilator in…
- Device Class II · moderate
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Covidien, LP — Product may contain a perforation or tear in the sterile barrier packaging. Thi…
- Device Class II · moderate
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Cata…
Cardinal Health 200, LLC — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled d…
- Device Class II · moderate
navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify Digital Pathology (Cloud) v2.5. M…
Ventana Medical Systems, Inc. — Due to complaints received for the Image Management System regarding image/meta…
- Device Class II · moderate
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO C…
Cardinal Health 200, LLC — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled d…
- Device Class II · moderate
Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product Number MSC351400AN
Medline Industries, LP — Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bl…
- Device Class II · moderate
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901; invitro diagnostics
Remel Europe Ltd. — Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performi…
- Device Class II · moderate
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Soft…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Two software related issues: 1) Potential image quality degradation that may le…
- Device Class II · moderate
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Erbe USA Inc — A strong pull on the high-pressure transfer hose of cryosurgical unit may lead …
- Device Class II · moderate
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOC…
Covidien, LP — Product may contain a perforation or tear in the sterile barrier packaging. Thi…
- Device Class II · moderate
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); imp…
Straumann USA LLC — Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may…
- Device Class II · moderate
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Cardinal Health 200, LLC — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled d…
- Device Class II · moderate
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, self-expanding endoprosthesis d…
W L Gore & Associates, Inc. — 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly la…
- Device Class II · moderate
Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Pro…
Spacelabs Healthcare, Inc. — Due to off-the-shelf display port component that has audio/video failures
- Device Class II · moderate
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and…
BD SWITZERLAND SARL — Products may not have received adequate sterilization processing.
- Device Class II · moderate
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-002…
Waldemar Link GmbH & Co. KG (Mfg Site) — The affected Endo-Model replacement set for a Rotating Hinge tibial plateau inc…
- Device Class II · moderate
Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) PACK NEURO MINOR CRANIOT…
Cardinal Health 200, LLC — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled d…
- Device Class II · moderate
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Straumann USA LLC — There may be a mismatch between the implant contained inside the packaging and …
- Device Class II · moderate
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Bioporto Diagnostics A/S — The use of a non-validated rework process for assay reagents which could lead t…
- Device Class II · moderate
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Covidien, LP — Product may contain a perforation or tear in the sterile barrier packaging. Thi…
- Device Class II · moderate
Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: S…
Cardinal Health 200, LLC — Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled d…
- Device Class II · moderate
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Covidien, LP — Product may contain a perforation or tear in the sterile barrier packaging. Thi…
- Device Class II · moderate
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1
OBP Medical Corporation — There is a potential for vaginal speculums to contain a burr on the proximal pl…
- Device Class II · moderate
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid …
BioFire Diagnostics, LLC — Due to increase in false negative results
- Device Class II · moderate
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223,…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential ima…
- Food Class I · high risk
Selectos Latinos Requeson Mexicano Mexican Cottage Cheese, Net Weight 16 oz, packed into retail-sized clear p…
La Colonia Foods Llc — Products may be contaminated with Listeria monocytogenes.
- Food Class I · high risk
Clover Hill Dairy LLP, mild cheese variety (Snack Pack Assorted Regular Mild Stix White Colby, Marble Jack, Y…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
Spicy Breakfast Burrito sold under the following brand names: FRESH & READY FOODS Spicy Breakfast Burrito Net…
M.G. Foods, Inc. — Undeclared Soy. The firm received complaints of sausage in the burritos. Upon r…
- Food Class I · high risk
Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Jalapeno Cheddar, Pepper Jack, Sizzlin Colby with Habane…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
Zen Principle Naturals Moringa Leaf Powder dietary supplement, 900mg capsules, 180 capsules per PET white bot…
FACTORY6, INC. — Possible Salmonella in Moringa Leaf Powder product.
- Food Class I · high risk
Clover Hill Dairy LLP, Mild Cheese Variety (Yummy Cheddar, White Cheddar, White Colby, Monterey Jack, Marble …
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (Snack Pack Assorted Pepperjack Stix (Jalapeno Cheddar, P…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class II · moderate
Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree, 4oz/113g pouch, UPC 815367010780, PTO Ite…
PT Organics Limited — Possible foreign object (thin, soft plastic strands).
- Food Class I · high risk
Clover Hill Dairy LLP, Soft Cuajada in Brine, sold in five (5) gallon and two (2) gallon buckets. Unknown inf…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
Clover Hill Dairy LLP, Sharp Cheese Snack Pack Sharp Stix White or Yellow. Sold in approximate 0.40-lb (6.4oz…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
KC Everyday Mac & Cheese, 3lb x 6. Item # 20609055. 6 - 3 lb pouches, Net Wt: 18 lb. (8.16Kg). Fully Cooked. …
Kerry, Inc — Undeclared allergen (egg)
- Food Class I · high risk
Clover Hill Dairy LLP, Pepper Jack Cheese Varieties (3-in-a-Pack Assorted Jalapeno Cheddar, Pepper Jack, Sizz…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
Clover Hill Dairy LLP, Soft Ricotta (Requeson), and Soft Ricotta with Jalapenos (Requeson Con Chile). Sold in…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
Clover Hill Dairy LLP, mild cheese variety (Fresh Cheddar Curd). Sold in approximate 0.75-lb and 1.5-lb box u…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class II · moderate
Flexible food pouch (3-layer foil, spouted, #CP6088), manufactured for packaging Pumpkin Tree Peter Rabbit Or…
CHEER PACK — Flexible food pouch may release thin plastic strips into food.
- Food Class I · high risk
Clover Hill Dairy LLP, Flavored Cheese (Old Bay Cheddar). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
Ashfiat Alharamain Energy Support 250ml/8fl. oz.
AKKARCO LLC — Undeclared tadalafil
- Food Class II · moderate
Big Way Hot Pot "Hot Pot Miso Paste"; 1kg (35.3oz) unit package. Product is packaged in generic bulk packagin…
Big Way Ca Inc — Undeclared milk from lactose.
- Food Class II · moderate
FLOUNDER SASHIMI WITH SAUCE; Keep Frozen; Net WT: 300g; UPC: 8 809342 366186
Eunha Fisheries Co., LTD — Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy,…
- Food Class I · high risk
Clover Hill Dairy LLP, Smoked Pepper Cheese Varieties (Jalapeno Cheddar), sold in 1/2-lb and 1-lb units. Unkn…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class II · moderate
Sliced Korean Halibut with Soy sauce, Wasabi, Vinegar Chili Paste; Keep Frozen; Net WT: 12.2OZ (374g); UPC: 6…
Eunha Fisheries Co., LTD — Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy,…
- Food Class I · high risk
Clover Hill Dairy LLP, Soft Cuajada crumbs. Unknown information: packaging, labeling, or total quantity of pr…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class II · moderate
"***Hondashi 0.25oz***" seasoning packed in silver plastic/metallic pouch, pouches packed in brown paperboard…
Pack'n Fresh LLC — Allergen missing from contains statement: fish
- Food Class I · high risk
Clover Hill Dairy LLP, Soft Cuajada (vacuum sealed), sold in 14oz- and 2.5 lb clam shells, and 5-lb bags. Unk…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
Clover Hill Dairy LLP, Smoked Cheddar Cheese Varieties (Cheddar, White Cheddar). Sold in 1/2-lb and 1-lb unit…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
Clover Hill Dairy LLP, Mild Cheese Variety (3-in-a-pack assorted White Colby, Marble Jack, Yummy Cheddar). So…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class III · low
Kanni Delight 31/40 Fresh Frozen Vannamei White Shrimp IQF, Raw Peeled & Deveined Tail Off, Gross Weight: 5 l…
CAMPO RICO FOODS LLC — Nitrofurans detected in product
- Food Class I · high risk
Selectos Latinos Requeson Salvadoreno Ricotta Style Salvadorean Cheese, Net Weight 14 oz, packed into retail-…
La Colonia Foods Llc — Products may be contaminated with Listeria monocytogenes.
- Food Class I · high risk
Clover Hill Dairy LLP, Cuajada (vacuum sealed), sold in 30-lb boxes. Unknown information: packaging, labeling…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
La Colonia Foods Salvadoreno Requeson Soft Ricotta, Net Wt: 14 oz (367g), packaged into retail-sized clear pl…
La Colonia Foods Llc — Products may be contaminated with Listeria monocytogenes.
- Food Class I · high risk
Clover Hill Dairy LLP, Flavored Cheese (horseradish). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Food Class I · high risk
Requeson, bulk product from Clover Hill Dairy packed into a plastic 18-lb bucket. Unknown labeling informatio…
La Colonia Foods Llc — Products may be contaminated with Listeria monocytogenes.
- Food Class II · moderate
Ultimate Mother's Day Wangshin Doenjang Aged 3 Years 9 oz. Korean Traditional Premium Soybean Paste UPC: 8 80…
JINA F&C — Product label allergen "contains" statement does not include anchovy(fish)
- Food Class I · high risk
Clover Hill Dairy LLP, sharp cheese variety (Cheddar, Yummy Cheddar, White Cheddar, Monterey Jack). Sold in a…
Clover Hill Dairy, LLC — Product contaminated with Listeria monocytogenes.
- Drug Class II · moderate
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, …
Aurobindo Pharma USA Inc — shortfill; reports of empty capsules.
- Drug Class I · high risk
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove…
Sunny Pharmtech Inc. — Presence of Particulate Matter; identified as stainless steel
- Drug Class III · low
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 m…
Central Admixture Pharmacy Services Inc — Incorrect Product Formulation
- Drug Class II · moderate
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd…
Zydus Pharmaceuticals (USA) Inc — CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurit…
- Drug Class I · high risk
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove…
Sunny Pharmtech Inc. — Presence of Particulate Matter; identified as stainless steel
- Device Class III · low
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Siemens Healthcare Diagnostics, Inc. — out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricycli…
- Device Class II · moderate
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9…
United Orthopedic Corp. — Due to an incomplete process of the component screw by a subcontractor which pr…
- Drug Class III · low
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manu…
Ascend Laboratories, LLC — Failed impurity/degradation specification: an OOS result observed in Related su…
- Drug Class III · low
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Man…
Ascend Laboratories, LLC — Failed impurity/degradation specification: an OOS result observed in Related su…
- Drug Class II · moderate
Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals…
Glenmark Pharmaceuticals Inc., USA — CGMP Deviations: Product quality complaints concerning abnormal texture or cons…
- Drug Class II · moderate
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufact…
MYLAN PHARMACEUTICALS INC — Presence of precipitate
- Drug Class II · moderate
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured b…
MICRO LABS USA INC — Defective Container: Firm received multiple complaints of broken cap spikes and…
- Drug Class III · low
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Ma…
Ascend Laboratories, LLC — Failed impurity/degradation specification: an OOS result observed in Related su…
- Drug Class II · moderate
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL …
Rohto-Mentholatum (Vietnam) Co., Ltd. — Lack of Assurance of Sterility
- Drug Class II · moderate
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx o…
Major Pharmaceuticals — Subpotent Drug
- Drug Class II · moderate
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL …
Rohto-Mentholatum (Vietnam) Co., Ltd. — Lack of Assurance of Sterility
- Drug Class II · moderate
Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx…
Major Pharmaceuticals — Subpotent Drug
- Drug Class III · low
Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Phar…
Supernus Pharmaceuticals, Inc. — Failed Dissolution Specifications
- Drug Class II · moderate
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx…
Major Pharmaceuticals — Subpotent Drug
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