FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Robeson Enterprises
- Product
- PIES & SIDES BAKED MAC AND CHEESE, ALLERGENS: MILK, PIES & S…
- Reason
- During an inspection by NCDA, the firm was notified that the label fails to declare the allergen egg as an ingredient or in the allergen statement. The firm was also notified that the label does not list any of the ingredients for their product.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Robeson Enterprises
- Product
- PIES & SIDES HASHBROWN CASSEROLE, ALLERGENS: MILK, WHEAT, SO…
- Reason
- During an inspection by NCDA, the firm was notified that the label does not list the ingredients for their products.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Robeson Enterprises
- Product
- PIES & SIDES GREEN BEAN CASSEROLE, CONTAINS: MILK, SOY, FISH…
- Reason
- During an inspection by NCDA, the firm was notified that the label does not list the ingredients for their products.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass I
Robeson Enterprises
- Product
- PIES & SIDES DEEP SOUTH TOMATO PIE, INGREDIENTS: SLICED TOMA…
- Reason
- The firm was notified that the label did not list any sub ingredients. The product contains pimento cheese which is made with mayonnaise which may include eggs. Undeclared eggs.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Robeson Enterprises
- Product
- PIES & SIDES CONNIE'S CARAMEL APPLE PIE 11 oz INGREDIENTS: A…
- Reason
- During an inspection by NCDA, the firm was notified that the label does not list the sub ingredients for their products.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Robeson Enterprises
- Product
- PIES & SIDES CHERRY PIE INGREDIENTS: CHERRY PIE FILLING, SUG…
- Reason
- During an inspection by NCDA, the firm was notified that the label does not list the sub ingredients for their products.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass III
Robeson Enterprises
- Product
- PIES & SIDES Broccoli Casserole Contains: Wheat, Eggs, Milk,…
- Reason
- During an inspection by NCDA, the firm was notified that the label does not list any ingredients in the product.
- Published
- April 17, 2024
- Distribution
- Products were shipped to the following s…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Whitley Peanut Factory, Inc.
- Product
- Whitley's Peanut Factory, Deluxe Nut Mix, 12oz (340g), Elect…
- Reason
- Undeclared Allergen (peanuts, milk, soy, wheat, and sesame).
- Published
- April 17, 2024
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
RAJA FOODS LLC
- Product
- SWAD BRAND CINNAMON POWDER in clear plastic 3.5 OZ bags, UPC…
- Reason
- Product tested positive for lead
- Published
- April 17, 2024
- Distribution
- NY, NJ, PA, MD, VA, CT, MA, NH, TN, FL,…
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FDA Recall
Terminated
Historical recordClass III
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
- Published
- April 10, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
- Published
- April 10, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
by IntegraDose Compounding Services LLC
- Reason
- Lack of Assurance of Sterility: leaking bags
- Published
- April 10, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
by B. Braun Medical Inc
- Reason
- Lack of assurance of sterility: bags have the potential to leak..
- Published
- April 10, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
- Published
- April 10, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Turkana Food Inc.
- Product
- Sekeroglu Lokum Love Turkish Delight With Pistachio And Pome…
- Reason
- Product contains Acid Red 18
- Published
- April 10, 2024
- Distribution
- Distributed to retail stores in CA, CT,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Turkana Food Inc.
- Product
- Sekeroglu Lokum Love Turkish Delight Mixed With Pistachio An…
- Reason
- Product contains Acid Red 18
- Published
- April 10, 2024
- Distribution
- Distributed to retail stores in CA, CT,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Waiakea Bottling Inc
- Product
- Waiakea Hawaiian Volcanic Water Naturally Alkaline Electrol…
- Reason
- Consumer complaints involving floating particles.
- Published
- April 10, 2024
- Distribution
- U.S. distribution to the following: PA,…
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FDA Recall
Ongoing
Historical recordClass I
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
by Par Sterile Products LLC
- Reason
- Presence of Particulate Matter.
- Published
- April 3, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Dissolution Specifications
- Published
- April 3, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
by Apothecus Pharmaceutical Corp.
- Reason
- cGMP Diviations
- Published
- April 3, 2024
- 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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