🏥 Medical Devices Class I - Dangerous
Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
All Recalls
95,114 total recalls in our database
Cub Scout activity pins
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The pin's face and shaft contain levels of lead that exceed the federal lead content ban. Lead is toxic if ingested by young children and can cause adverse health issues.
Baby Strollers
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The recalled strollers violate the Federal Standard for Carriages and Strollers. A child's torso can pass through the opening between the activity tray and the seat bottom and his/her head can become entrapped, posing entrapment and strangulation hazards. The location of the crotch restraint creates a large opening between the seat bottom and the restraint, posing a fall hazard to children.
Captain Rusty's Smoked Mahi Dip, Made with real Mahi meat, Keep Refrigerated, 6 lb.
Captain Rusty's Seafood Products
🍎 Food Class I - Dangerous
Undeclared major allergens (egg and soy) in "Captain Rusty's" brand Smoked Mahi Dip uncovered during FDACS routine inspection.
Captain Rusty's Blue Crab Dip, Made with real Blue Crab meat, Keep Refrigerated,16 oz.
Captain Rusty's Seafood Products
🍎 Food Class I - Dangerous
Undeclared major allergens (fish, egg, soy, milk, and wheat) in "Captain Rusty's" brand Blue Crab Dip uncovered during FDACS routine inspection.
Captain Rusty's Cajun Crab & Lobster Dip, Made with real Blue Crab and Lobster meat, Keep Refrigerated,16 oz.
Captain Rusty's Seafood Products
🍎 Food Class I - Dangerous
Undeclared major allergens (fish, egg, soy, milk, wheat, and crustacean shellfish) in "Captain Rusty's" brand Cajun Crab & Lobster Dip uncovered during FDACS routine inspection.
Captain Rusty's Smoked Salmon Dip, A Taste of the Pacific Coast, Keep Refrigerated, 16 oz.
Captain Rusty's Seafood Products
🍎 Food Class I - Dangerous
Undeclared major allergen (milk) in "Captain Rusty's" brand Smoked Salmon Dip uncovered during FDACS routine inspection.
Captain Rusty's Lobster Dip, Made with real Lobster meat, Keep Refrigerated,16 oz.
Captain Rusty's Seafood Products
🍎 Food Class I - Dangerous
Undeclared major allergens (fish, egg, soy, milk, wheat, and crustacean shellfish) in "Captain Rusty's" brand Lobster Dip uncovered during FDACS routine inspection.
Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30
Aurobindo Pharma USA
💊 Drugs Class I - Dangerous
Failed Impurities/ Degradation Specifications
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
Glaxosmithkline Consumer Healthcare Holdings
💊 Drugs Class I - Dangerous
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
SCA Pharmaceuticals
💊 Drugs Class I - Dangerous
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
💊 Drugs Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
💊 Drugs Class I - Dangerous
Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations.
💊 Drugs Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01
Hikma Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0574-41
Glaxosmithkline Consumer Healthcare Holdings
💊 Drugs Class I - Dangerous
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
💊 Drugs Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
Aurobindo Pharma USA
💊 Drugs Class I - Dangerous
Failed Impurities/ Degradation Specifications
Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single pack and twin pack, Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0095-41
Glaxosmithkline Consumer Healthcare Holdings
💊 Drugs Class I - Dangerous
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01
Hikma Pharmaceuticals USA
💊 Drugs Class I - Dangerous
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.