FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Severino Pasta Manufacturing, Inc.
- Product
- Severino Home Made, Artisanal Small Batch Pasta, Raviolini…
- Reason
- Severino Pasta Manufacturing, Inc. has initiated a recall of their Severino Pasta Super Fresh Cheese Raviolini due to undeclared eggs. The retail unit has the correct label on top, Cheese Raviolini which declares the precense of eggs in the ingredient statement and contains statement. However, the product has the incorrect label on the bottom, Cheese Rigatoni, which does not declare eggs in the ingredient statement or contains statement. The Raviolini label declares: Wheat, Milk, and Eggs whereas the Rigatoni label declares: Wheat and Milk. Since both labels are on the product consumers may be confused as to which ingredients are actually present.
- Published
- August 22, 2018
- Distribution
- Product was distributed to Whole Foods M…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0391 Confidence, Glucosamine Plus, With Hyaluronic Acid +…
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin.
- Published
- August 22, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0692, Confidence, Prenatal Multi-V + DHA, 90 tablets per b…
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin, FD&C Yellow #6 (Sunset Yellow FCF), FD&C Red #40 (Allura Red AC), FD&C Yellow #5 (Tartrazine), and FD&C Blue #2 (Indigotine).
- Published
- August 22, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0292 Confidence Nitro-Cross 60s, UPC# 8 92483 00155 7
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol 400 and 800 (PEG), Triacetin
- Published
- August 22, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0392, Confidence, Glucosamine Plus, with White Willow Bark…
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol 400 and 800 (PEG), Triacetin
- Published
- August 22, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Saratoga Food Specialties, Inc.
- Product
- Pizza Hut Seasoning Breadstick 10 pound case, 5 X 2 lb. pa…
- Reason
- Saratoga Food Specialties, has initiated a voluntary recall of Pizza Hut Seasonings following their supplier's recall of dry whey powder due to the potential presence of Salmonella
- Published
- August 22, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada UPC# 6 02401 88900 2
by World Organix, LLC
- Reason
- Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
- Published
- August 15, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4
by World Organix, LLC
- Reason
- Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
- Published
- August 15, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 14983 56525 7
by World Organix, LLC
- Reason
- Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
- Published
- August 15, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.
by World Organix, LLC
- Reason
- Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
- Published
- August 15, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3
by World Organix, LLC
- Reason
- Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
- Published
- August 15, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
- Published
- August 15, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361
by Right Value Drug Stores, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
- Published
- August 15, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
by Akorn, Inc.
- Reason
- Failed Impurities/Degredation Specifications: Out of Specification results for an unknown impurity was found during routine stability testing at 12 months.
- Published
- August 15, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.
by Morton Grove Pharmaceuticals, Inc.
- Reason
- Defective Container: Tamper Evident foil seal not completely intact.
- Published
- August 15, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20.
by Valeant Pharmaceuticals North America LLC
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
- Published
- August 15, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
by Pharmalucence, Inc.
- Reason
- Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
- Published
- August 15, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.
by Baxter Healthcare Corporation
- Reason
- Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Published
- August 15, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.
by Baxter Healthcare Corporation
- Reason
- Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Published
- August 15, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.
by Baxter Healthcare Corporation
- Reason
- Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Published
- August 15, 2018
- 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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