Safety Recalls

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15,259 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 4,901–4,950 of 15,259

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 (Individual
Presence 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
DermaRite Industries, LLC
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, 7777
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
Drug Recall · August 27, 2025
DermaRite Industries, LLC
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 Avenue
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II
Drug Recall · August 27, 2025
DermaRite Industries, LLC
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
Medical Device Recall · August 27, 2025
Vision RT Ltd
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
Food Recall · August 27, 2025
Middlefield Original Cheese Cooperative
Middlefield Original Cheese Co-op Smoked Cheddar, 5 lb. loaves, packaged 8 loaves per case
Potential contamination with Listeria monocytogenes
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 case
Potential 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 an
Potential contamination with Listeria monocytogenes
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 case
Potential contamination with Listeria monocytogenes
Class I
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 NDC
Presence 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
Food Recall · August 26, 2025
Extract Labs, Inc.
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 (c
Potential peanut protein cross-contact.
Class II
Medical Device Recall · August 26, 2025
W L Gore & Associates, Inc.
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
Extract Labs, Inc.
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
Drug Recall · August 26, 2025
B BRAUN MEDICAL INC
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
Drug Recall · August 26, 2025
B BRAUN MEDICAL INC
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
Food Recall · August 26, 2025
Extract Labs, Inc.
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 (con
Potential peanut protein cross-contact.
Class II
Food Recall · August 26, 2025
Country Eggs, LLC
o Nagatoshi Large AA Brown Omega-3 1 dozen cartons o Nijiya Large AA Brown Golden Yolk 1 dozen cartons o Mizuho Large AA Brown Omega-3 Cage 1 dozen cartons o Country Eggs Large AA Brown Sunshine Yolk
Shell egg product potentially contaminated with salmonella.
Class I
Food Recall · August 26, 2025
Extract Labs, Inc.
Sugar-free Mixed Berry Gummies Brand Name: Extract Labs Generic Name: Dietary Supplement Strength: 10mg CBD and 10mg D9 THC per gummy Dosage: 1 gummy Form: Gummy Administration: Oral Intended use
Potential peanut protein cross-contact.
Class II
Medical Device Recall · August 26, 2025
OSSTEM Implant Co., Ltd.
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.
Class II
Medical Device Recall · August 26, 2025
OSSTEM Implant Co., Ltd.
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.
Class II
Medical Device Recall · August 26, 2025
OSSTEM Implant Co., Ltd.
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 25, 2025
LeMaitre Vascular, Inc.
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or repla
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
Class II
Drug Recall · August 25, 2025
AvKARE
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
Presence of a foreign substance.
Class II
Drug Recall · August 25, 2025
Consumer Product Partners, LLC
TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
Cross Contamination with Other Products.
Class III
Drug Recall · August 25, 2025
Consumer Product Partners, LLC
Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
Cross Contamination with Other Products.
Class III
Drug Recall · August 25, 2025
AvKARE
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
Presence of a foreign substance.
Class II
Food Recall · August 25, 2025
Abdallah Incorporated
Cream Caramels, Milk, Item ID: 2210L. Packed On (YYMMDD): 25-06-16. 6.26 lb. Box. Abdallah Candies
Undeclared allergen (peanut, pecan).
Class II
Food Recall · August 25, 2025
Abdallah Incorporated
Sea Salt Caramel Dark Miniature, Item ID: 2237 ML. Packed On (YYMMDD): 25-07-22. 5.20 lb. Box. Abdallah Candies
Undeclared allergen (peanut, pecan).
Class II
Medical Device Recall · August 22, 2025
CooperVision, Inc.
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable W
One lot manufactured with an invalid sterilization cycle.
Class II
Medical Device Recall · August 22, 2025
CooperVision, Inc.
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Dai
One lot manufactured with an invalid sterilization cycle.
Class II
Medical Device Recall · August 22, 2025
Sonesta Medical AB
Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the u
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
Class II
Drug Recall · August 22, 2025
GRACE & FIRE PTY LTD
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Dis
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II
Drug Recall · August 22, 2025
GRACE & FIRE PTY LTD
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106
Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
Class II
Medical Device Recall · August 22, 2025
CooperVision, Inc.
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Bli
One lot manufactured with an invalid sterilization cycle.
Class II
Medical Device Recall · August 22, 2025
GE Medical Systems, LLC
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
Class II
Medical Device Recall · August 21, 2025
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Class II
Medical Device Recall · August 21, 2025
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Class II
Medical Device Recall · August 21, 2025
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Class II
Food Recall · August 21, 2025
Taylor Farms Retail, Inc.
Salad Kit labeled as follows: Taylor FARMS Honey Balsamic SALAD KIT, NET WT. 8.3 OZ (235g), INGREDIENTS: HONEY BALSAMIC VINAIGRETTE (soybean oil ...) SPINACH, CARROT, SEA SALT CROISSANT CROUTON (wheat
Undeclared allergens (sesame and soy).
Class I
Medical Device Recall · August 21, 2025
Bard Peripheral Vascular Inc
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sop
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.
Class II
Medical Device Recall · August 21, 2025
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Class II
Food Recall · August 21, 2025
Blue Bell Creameries, L.P.
Chocolate Chip Cookie Dough ice cream cartons with a Moo-llennium Crunch lid. Packaging contains Moo-llennium crunch. Packaged in half gallon cartons (1.89 L)
undeclared almond, walnut, and pecan.
Class II
Medical Device Recall · August 21, 2025
Abbott Point Of Care Inc.
i-STAT EG7+ cartridge. List Number: 03P76-25.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Class II
Medical Device Recall · August 21, 2025
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Class II
Medical Device Recall · August 21, 2025
Abbott Point Of Care Inc.
i-STAT EG6+ cartridge. List Number: 03P77-25.
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Class II
Food Recall · August 21, 2025
Latitude 36 Foods
Honey Balsamic dressing, 3.4 ounce plastic pouch, Best by date and Lot number appear directly on pouch.
Product contains undeclared Soy and Sesame
Class I
Medical Device Recall · August 21, 2025
Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.
Class II
Medical Device Recall · August 21, 2025
Medline Industries, LP
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
The kits contain certain lots of cannula products where the catheter may not retain its shape.
Class I
Medical Device Recall · August 21, 2025
Abbott Point Of Care Inc.
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.
Class II
Medical Device Recall · August 21, 2025
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Labeling includes shelf life that has not been validated.
Class II