FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mount Franklin Foods LLC DBA Azar Nut Co.
- Product
- Power Snacks Honey Roasted Sunflower Kernels, Net Wt 1 oz; U…
- Reason
- Potential to contain undeclared soy and/or wheat allergen due to mislabeling.
- Published
- September 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
by Hua Da Trading, Inc. dba Wefun Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16
by VistaPharm LLC
- Reason
- Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials, NDC 71839-122-10; (b) 25 Single-dose vials, NDC 71839-122-25; Rx Only, Mfd. in India for and Distributed by: BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511.
by BE PHARMACEUTICALS AG
- Reason
- Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Conopco DBA Unilever
- Product
- Knorr Letras con Tomate Tomato Based Alphabet Pasta Soup Mix…
- Reason
- Undeclared egg
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Conopco DBA Unilever
- Product
- Knorr Fideos con Tomate Tomato Based Pasta Soup Mix 3.5 oz U…
- Reason
- Undeclared egg
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Conopco DBA Unilever
- Product
- Knorr Estrellitas con Tomate Tomato Based Star Pasta Soup Mi…
- Reason
- Undeclared egg
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Twin City Foods, Inc.
- Product
- Mixed Vegetables BEST PRICE TOPVALU, net per bag 500g. Label…
- Reason
- Listeria monocytogenes
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Twin City Foods, Inc.
- Product
- Kernel Corn, BEST PRICE TOPVALU, net wt. per bag 300g. Label…
- Reason
- Listeria monocytogenes
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Twin City Foods, Inc.
- Product
- Individually Quick Frozen (IQF) Corn, distributed in bulk ca…
- Reason
- Listeria monocytogenes
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Twin City Foods, Inc.
- Product
- Individually Quick Frozen (IQF) Corn distributed in BULK TOT…
- Reason
- Listeria monocytogenes
- Published
- September 20, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
by Marlex Pharmaceuticals, Inc.
- Reason
- Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
- Published
- September 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
by Marlex Pharmaceuticals, Inc.
- Reason
- Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
- Published
- September 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57
by Ascend Laboratories, LLC
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
- Published
- September 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10
by Caplin Steriles Limited
- Reason
- Failed Impurities/Degradation Specifications
- Published
- September 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03
by Esperion
- Reason
- Failed dissolution specifications: below specification results at stability 12-month
- Published
- September 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
by APG SEVEN, INC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65
by Lundbeck LLC
- Reason
- Cross contamination with other products
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- Published
- September 6, 2023
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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