FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Bella Brands, LLC DBA Bella Cucina Artful Food
- Product
- Bella Cucina Artful Food Arugula & Pine Nut Pesto Net Wt. 6…
- Reason
- Label does not indicate milk on the label.
- Published
- November 9, 2022
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Bella Brands, LLC DBA Bella Cucina Artful Food
- Product
- Bella Cucina Artful Food Artichoke Lemon Pesto Net Wt. 3.5 o…
- Reason
- Label does not indicate milk on the label.
- Published
- November 9, 2022
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Domino Foods Inc
- Product
- Domino and C&H Granulated Pure Cane Sugar Easy Baking Tub pa…
- Reason
- Potential to contain metal wire from broken screen
- Published
- November 9, 2022
- Distribution
- Product was distributed to distribution…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Kabobs Acquisition Inc.
- Product
- BRIE EN CROUTE WITH RASPBERRY
- Reason
- The firm was notified by their Brie Cheese supplier that the product may be contaminated with Listeria monocytogenes.
- Published
- November 9, 2022
- Distribution
- Product was shipped to one distributor i…
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FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
- Published
- November 2, 2022
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Published
- November 2, 2022
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10
by Golden State Medical Supply Inc.
- Reason
- Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
- Published
- November 2, 2022
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
by VistaPharm, Inc.
- Reason
- cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
- Published
- November 2, 2022
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
by Ultra Chem Labs Corp
- Reason
- Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
- Published
- November 2, 2022
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
by Ultra Chem Labs Corp
- Reason
- Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
- Published
- November 2, 2022
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)
by AuroMedics Pharma LLC
- Reason
- Subpotent Drug: Out of specification for assay
- Published
- November 2, 2022
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Cuisine Innovations Unlimited, LLC
- Product
- Earth Grown Vegan Garlic & Herb Falafel NET WT 12 OZ (340g),…
- Reason
- Possible presence of Shiga toxin-producing E. coli.
- Published
- November 2, 2022
- Distribution
- Distributed to Distributors in IL, MO, K…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Cuisine Innovations Unlimited, LLC
- Product
- Earth Grown Vegan Traditional Falafel NET WT 12 OZ (340g), 1…
- Reason
- Possible presence of Shiga toxin-producing E. coli.
- Published
- November 2, 2022
- Distribution
- Distributed to Distributors in IL, MO, K…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
The Chai Box
- Product
- THE CHAI BOX CHAI CONCENTRATE UNSWEETENED 16FL OZ/473ML glas…
- Reason
- Potential to be contaminated with Clostridium botulinum. Product was tested and found to have pH level of 4.9.
- Published
- November 2, 2022
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
The Chai Box
- Product
- THE CHAI BOX CHAI CONCENTRATE 16FL OZ/473ML glass bottles UP…
- Reason
- Potential to be contaminated with Clostridium botulinum. Product was tested and found to have pH level of 4.9.
- Published
- November 2, 2022
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Secrets Of The Tribe
- Product
- Indian Gooseberry Alcohol-Free Extract, 2 oz. glass bottle,…
- Reason
- Product has elevated level of lead.
- Published
- November 2, 2022
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Secrets Of The Tribe
- Product
- Amla Alcohol-Free Extract, 2 oz. glass bottle, UPC 041979376…
- Reason
- Product has elevated level of lead.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Tomoorona LLC
- Product
- Qassim Mix for Coffee, Net Weight 125g, packaged in a plasti…
- Reason
- The product is labeled to contain sodium caseinate, a milk derivative, but the label does not declare the product contains "milk."
- Published
- November 2, 2022
- Distribution
- Distributed to retail stores in IN, GA,…
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FDA Recall
Ongoing
Historical recordClass II
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Published
- October 26, 2022
- 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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