FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ozona Organics LLC
- Product
- OZONA ORGANICS LIQUID PROBIOTICS & GO HEALTHY LIQUID PROBIOT…
- Reason
- Products contain high water activity in the formula that provides a potential for microbial growth.
- Published
- October 4, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002
by HUMANRACE
- Reason
- Subpotent Drug: Product does not contain SPF that is declared on the label.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01
by HUMANRACE
- Reason
- Subpotent Drug: Product does not contain SPF that is declared on the label.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
by Novartis Pharmaceuticals Corp.
- Reason
- Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Subpotent: Out of Specification result observed for low assay
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
by Aurobindo Pharma USA Inc.
- Reason
- Failed dissolution specifications - results obtained were below spec average.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case).
by CareFusion 213, LLC
- Reason
- Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mount Franklin Foods LLC DBA Azar Nut Co.
- Product
- 1. 7 Select Cashews Halves & Pieces Honey Roasted, Net Wt 3…
- Reason
- Potential to contain undeclared soy and/or wheat allergen due to mislabeling.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mount Franklin Foods LLC DBA Azar Nut Co.
- Product
- Circle K Honey Roasted Peanuts, Net Wt 2.5 oz, UPC 194283102…
- Reason
- Potential to contain undeclared soy and/or wheat allergen due to mislabeling.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mount Franklin Foods LLC DBA Azar Nut Co.
- Product
- 1. Circle K Get Up Trail Mix, Net Wt 2 oz, UPC 194283102893…
- Reason
- Potential to contain undeclared soy and/or wheat allergen due to mislabeling.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mount Franklin Foods LLC DBA Azar Nut Co.
- Product
- Circle K Sweet & Spicy Mix, Net Wt 7 oz; UPC 194283104613
- Reason
- Potential to contain undeclared soy and/or wheat allergen due to mislabeling.
- Published
- September 27, 2023
- Distribution
- Nationwide
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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
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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
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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
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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
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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
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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 →
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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