FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- Organic Hard Cooked Eggs sold under the brand names of Almar…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- Eggland's Best Hard Cooked Eggs
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- Almark Foods Classic ProBox Classic Flavor - Cage Free Eggs
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- Cage Free Hard-Cooked Eggs sold under the following brand na…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Almark Foods, LLC
- Product
- Bulk Pail Product - Almark Foods HARD COOKED EGGS Peeled Egg…
- Reason
- The firm was notified by FDA & CDC of a potential Listeria monocytogenes genetic match between environmental samples from our facility and case patient samples associated with an illness outbreak.
- Published
- February 12, 2020
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CATSMO LLC
- Product
- Daniel Boulud brand Baja flavored (8oz) smoked salmon produc…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 12, 2020
- Distribution
- NY, CT, NJ, MN, NC, FL, VA, MA, IL, PA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CATSMO LLC
- Product
- Catsmo brand Red Beet (4oz.) smoked salmon products manufact…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 12, 2020
- Distribution
- NY, CT, NJ, MN, NC, FL, VA, MA, IL, PA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CATSMO LLC
- Product
- Catsmo brand Gravelox (4oz) smoked salmon products manufactu…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- February 12, 2020
- Distribution
- NY, CT, NJ, MN, NC, FL, VA, MA, IL, PA,…
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
by Pharmaceutical Associates Inc
- Reason
- Subpotent: Out of specification for assay at the 12-month time point.
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
by Macleods Pharma Usa Inc
- Reason
- Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11
by Shandex Personal Care Manufacturing Inc.
- Reason
- Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Jeni's Splendid Ice Creams LLC
- Product
- Jeni's Dairy Free Cold Brew with Coconut Cream Pints frozen…
- Reason
- May contain undeclared milk allergen
- Published
- February 5, 2020
- Distribution
- Product distributed to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ingredion Incorporated
- Product
- Ingredion ULTRA-TEX4 Food Starch in 50lb paper bags, product…
- Reason
- Foreign material. Potential for fragments of stainless steel wire in the product. Fragments are approximately 0.19mm in diameter with varying lengths of 1mm 20mm in length.
- Published
- February 5, 2020
- Distribution
- CA, GA, IL, MN, MO, NC, NJ, OH Australi…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dianne's Fine Desserts
- Product
- Sienna Chocolate Turtle Brownie (frozen); 108 OZ (6.75 LB)…
- Reason
- Brownie product contains undeclared peanuts
- Published
- February 5, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich…
- Reason
- Potential to contain undeclared milk and coconut.
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes…
- Reason
- Potential to contain undeclared milk.
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
by Hikma Pharmaceuticals USA Inc.
- Reason
- Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
by Tuscano and Delucia Group (DBA Entropic Labs)
- Reason
- Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.
by Advanced Accelerator Applications USA, Inc.
- Reason
- Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
by Denton Pharma, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 29, 2020
- 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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