FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Fusion Health and Vitality LLC
- Product
- PHARMORIGINS CORE with Natural Orange Flavor NATURAL ENERGY…
- Reason
- The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements
- Published
- December 23, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Out of the Kitchen, LLC
- Product
- Chef Mitch Maier's Black Garlic Ketchup. Net Wt. 19 oz. (53…
- Reason
- Specific Chef Mitch Maier's Black Garlic BBQ Sauces and Marinades may develop mold prior to the Best By date.
- Published
- December 23, 2020
- Distribution
- IL and WI.
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Out of the Kitchen, LLC
- Product
- Chef Mitch Maier's Black Garlic Sauce. Net Wt. 16 oz. (473g…
- Reason
- Specific Chef Mitch Maier's Black Garlic BBQ Sauces and Marinades may develop mold prior to the Best By date.
- Published
- December 23, 2020
- Distribution
- IL and WI.
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Out of the Kitchen, LLC
- Product
- Chef Mitch Maier's Black Garlic BBQ Sauce. Net Wt. 19 oz. (…
- Reason
- Specific Chef Mitch Maier's Black Garlic BBQ Sauces and Marinades may develop mold prior to the Best By date.
- Published
- December 23, 2020
- Distribution
- IL and WI.
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FDA Recall
Terminated
Historical recordClass III
Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90
by Novocol Pharmaceutical of Canada, Inc.
- Reason
- Labeling: Label mix-up
- Published
- December 16, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.
by Shilpa Medicare Limited
- Reason
- CGMP Deviations
- Published
- December 16, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05
by Fresenius Kabi USA, LLC
- Reason
- Cross Contamination with other products: trace amounts of lidocaine
- Published
- December 16, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hy-Vee Stores Inc
- Product
- Hy-Vee, Short Cuts, Pot Roast Mix sold by weight in approxim…
- Reason
- An ingredient used as an ingredient in the products tested positive for Listeria monocytogenes
- Published
- December 16, 2020
- Distribution
- To Hy-Vee stores in IA, IL, KS, MN, MO,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hy-Vee Stores Inc
- Product
- Hy-Vee, Short Cuts, Grill Ready Veggie Mix sold by weight in…
- Reason
- An ingredient used as an ingredient in the products tested positive for Listeria monocytogenes
- Published
- December 16, 2020
- Distribution
- To Hy-Vee stores in IA, IL, KS, MN, MO,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- HomeChef meal kit:Steak and Walnut-Green Onion Sauce with ro…
- Reason
- Supplier provided ingredient (pretzel breading) was SUSPECT for Listeria species, but no further confirmation was performed to confirm the suspect result. Lot number of ingredient in question: 0924032501
- Published
- December 16, 2020
- Distribution
- Alabama, Arizona, Arkansas, California,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- HomeChef meal kit: Buffalo Pretzel Chicken Breast with Roast…
- Reason
- Supplier provided ingredient (pretzel breading) was SUSPECT for Listeria species, but no further confirmation was performed to confirm the suspect result. Lot number of ingredient in question: 0924032501
- Published
- December 16, 2020
- Distribution
- Alabama, Arizona, Arkansas, California,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Kroger Co
- Product
- HomeChef Meal kit:One-Sheet Pretzel-Crusted Chicken with roa…
- Reason
- Supplier provided ingredient (pretzel breading) was SUSPECT for Listeria species, but no further confirmation was performed to confirm the suspect result. Lot number of ingredient in question: 0924032501
- Published
- December 16, 2020
- Distribution
- Alabama, Arizona, Arkansas, California,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
PRAIRIE FARMS
- Product
- Prairie Farms Premium Flavored Chocolate Milk, 1 gallon, UPC…
- Reason
- The product contains undeclared egg.
- Published
- December 16, 2020
- Distribution
- retail outlets in the Chicago area, incl…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
PRAIRIE FARMS
- Product
- Prairie Farms 1% Lowfat Chocolate Milk, 1 gallon, UPC 72730-…
- Reason
- The product contains undeclared egg.
- Published
- December 16, 2020
- Distribution
- retail outlets in the Chicago area, incl…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
JMH International, LLC
- Product
- Chef Myron's Premium Shoyu Sauce, 1 GAL (3.78 L), Item # 400…
- Reason
- Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.
- Published
- December 16, 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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