Safety Recalls
RSS ↗17,567 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 6,451–6,500 of 17,567
- Class III
Drug Recall · August 28, 2025
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mFailed Impurities/Degradation Specifications:
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Verio. Model Number: 10276755.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class I
Medical Device Recall · August 28, 2025
Siemens Medical Solutions USA, Inc
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
- Class II
Medical Device Recall · August 27, 2025
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
- Class II
Drug Recall · August 27, 2025
Amerisource Health Services LLC
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (IndividualPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Class I
Food Recall · August 27, 2025
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Shredded Mozzarella Cheese, 5 lb., shredded in a plastic bag and packed 4 bags per casePotential contamination with Listeria monocytogenes
- Class I
Food Recall · August 27, 2025
Middlefield Original Cheese Cooperative
1) Middlefield Original Cheese Co-op All Natural Pepper Jack Cheese, packaged as 5 lb. loaves wrapped in plastic and packed 2 loaves per case (distribution) or 8 loaves per case (retail), or sliced anPotential contamination with Listeria monocytogenes
- Class II
Drug Recall · August 27, 2025
Amerisource Health Services LLC
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual DoPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Class II
Drug Recall · August 27, 2025
KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West SCGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class I
Food Recall · August 27, 2025
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Original Swiss Cheese, packaged as 5 lb. loaves wrapped in plastic and packed 2 loaves per case (distribution) or 8 loaves per case (retail), or sliced and packaged aPotential contamination with Listeria monocytogenes
- Class I
Food Recall · August 27, 2025
Middlefield Original Cheese Cooperative
1) Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles, Net Wt. 6 oz., packaged individually in plastic, packed 12 per case, UPC: 810665011156 2) Sunrise Creamery Dilly Pickle Jack MPotential contamination with Listeria monocytogenes
- Class II
Drug Recall · August 27, 2025
PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North BerCGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
Amerisource Health Services LLC
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDCPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Class I
Food Recall · August 27, 2025
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Smoked Cheddar, 5 lb. loaves, packaged 8 loaves per casePotential contamination with Listeria monocytogenes
- Class II
Drug Recall · August 27, 2025
Atlantic Management Resources Ltd.
Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01cGMP violations
- Class II
Drug Recall · August 27, 2025
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12ozCGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), aCGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side AvenueCGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class I
Food Recall · August 27, 2025
Middlefield Original Cheese Cooperative
1) Middlefield Original Cheese Co-op Monterey Jack, 5 lb., packaged as loaves wrapped in plastic and packed 8 loaves per case 2) Middlefield Original Cheese Co-op Provolone, 5 lb., packaged as loavesPotential contamination with Listeria monocytogenes
- Class I
Drug Recall · August 27, 2025
Unichem Pharmaceuticals USA Inc.
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: UnichemLabeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
- Class II
Drug Recall · August 27, 2025
Zydus Pharmaceuticals (USA) Inc
Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus PharmaceuticFailed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
- Class II
Drug Recall · August 27, 2025
McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DCGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 070CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class II
Drug Recall · August 27, 2025
Amerisource Health Services LLC
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (IndiviPresence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Class II
Drug Recall · August 27, 2025
DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC,CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class I
Food Recall · August 27, 2025
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Shredded Mozzarella/Provolone Cheese, 5 lbs., packaged in a plastic bag, packed 4 bags per casePotential contamination with Listeria monocytogenes
- Class II
Drug Recall · August 27, 2025
UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class I
Food Recall · August 27, 2025
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Organic Gouda Cheese, 8 oz., packaged individually in plastic, packed 12 per casePotential contamination with Listeria monocytogenes
- Class II
Drug Recall · August 27, 2025
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- Class I
Food Recall · August 27, 2025
Middlefield Original Cheese Cooperative
1) Middlefield Original Cheese Co-op All Natural Mild Cheddar Cheese, 5 lb., packaged as individual loaves wrapped in plastic, packed 2 loaves per case (distribution) or 8 loaves per case (retail) 2)Potential contamination with Listeria monocytogenes
- Class II
Medical Device Recall · August 26, 2025
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A,Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
- Class II
Food Recall · August 26, 2025
Blue Razz 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (cPotential peanut protein cross-contact.
- Unclassified
Vehicle Recall · August 26, 2025
2025 HYUNDAI SANTA FE, 2025 HYUNDAI TUCSONA loss of drive power increases the risk of a crash. An oil leak in the presence of hot engine components can increase the risk of an engine compartment fire.
- Unclassified
Vehicle Recall · August 26, 2025
2025 POLESTAR POLESTAR 3A detached bumper can become a road hazard, increasing the risk of a crash.
- Class II
Food Recall · August 26, 2025
Elderberry 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (Potential peanut protein cross-contact.
- Class II
Food Recall · August 26, 2025
Mai Tai 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (conPotential peanut protein cross-contact.
- Class II
Drug Recall · August 26, 2025
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
- Class II
Drug Recall · August 26, 2025
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
- Class II
Medical Device Recall · August 26, 2025
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
- Unclassified
Vehicle Recall · August 26, 2025
2025 FOREST RIVER RIVERSTONEA brake fluid leak can cause a loss of brake function, increasing the risk of a crash.
- Class II
Medical Device Recall · August 26, 2025
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.
- Class II
Medical Device Recall · August 26, 2025
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.