689 recalls tagged with “fda regulated”.
AvKare recalled 2,003 cartons of Chlorpromazine Hydrochloride Tablets on August 25, 2025. The recall stems from the presence of a foreign substance in the medication. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Abdallah Candies recalled Sea Salt Caramel Dark Miniature on August 25, 2025. The recall affects one 5.20 lb box due to undeclared allergens. Consumers should not consume the product and seek a refund immediately.
AvKare recalled 1,512 cartons of Chlorpromazine Hydrochloride Tablets on August 25, 2025. The recall follows the discovery of a foreign substance in the medication. Consumers should stop using the product immediately and seek guidance from healthcare providers.
LeMaitre Vascular recalled 10 Artegraft Collagen Vascular Grafts on August 25, 2025, due to incorrect labeling. The devices lack CE and UKCA marks and are missing essential patient information. No distribution occurred within the U.S., but the affected products were sent to Great Britain and Switzerland.
Ultra Violette recalled 44,497 tubes of its Mini SPF Mates kit on August 22, 2025. The sunscreen products showed inconsistent SPF results, including readings as low as SPF 4. Consumers must stop use immediately and contact the distributor for guidance.
Abbott Point Of Care recalled 6,115,950 i-STAT EG7+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance for updated measurement ranges. This issue affects the accuracy of potassium and ionized calcium tests, posing a high risk to patients.
Folsom Metal Products recalled 10 double packs of 14 mm Distraction Pins on August 21, 2025. The recall affects devices with unvalidated shelf life labeling. Healthcare providers and patients must stop using these devices immediately.
Folsom Metal Products recalled 160 units of distraction pins due to unvalidated shelf life labeling. The recall affects devices distributed across multiple states, including California and Texas. Patients and healthcare providers should stop using the product immediately.
Folsom Metal Products recalled 490 units of its 16 mm distraction pin on August 21, 2025. The recall affects devices with unvalidated shelf life labeling. Patients and healthcare providers must stop using the device immediately.
Abbott Point Of Care recalled 547,250 i-STAT EG6+ cartridges on August 21, 2025. The recall stems from a lack of 510(k) premarket clearance for updated sample types and measurement ranges. Healthcare providers and patients must stop using these cartridges immediately.
Latitude 36 Foods recalled 46,800 units of Honey Balsamic dressing on August 21, 2025. The dressing contains undeclared soy and sesame, posing a serious health risk. Consumers should not consume the product and seek a refund.
Taylor Farms recalled 8,284 units of its Honey Balsamic Salad Kit on August 21, 2025. The recall stems from undeclared allergens including sesame and soy. Consumers should not consume the affected products and seek refunds or replacements.
Folsom Metal Products recalled 10,960 units of 14 mm Distraction Pins on August 21, 2025. The recall follows concerns that the labeling included an unvalidated shelf life. Healthcare providers and patients must stop using the device immediately.
Itacate Foods recalled 566 packages of CHARGE-UP CHILAQUILES on August 20, 2025. The product contains undeclared Yellow #5 and Yellow #6, posing a health risk. Consumers should not consume the product and seek a refund or replacement.
Northwind Pharmaceuticals recalled Sulfamethoxazole and Trimethoprim Tablets on August 20, 2025. The recall affects several lot numbers due to a foreign substance found in packaging. Consumers should stop using the product and seek guidance immediately.
Boston Scientific recalled 41,009 pacemakers on August 20, 2025, due to a software issue that could trigger Safety Mode. This affects the ACCOLADE family of devices, including the PROPONENT model. Patients should stop using these devices immediately and contact their healthcare provider.
Boston Scientific recalled 4,055 ALTRUA 2 DR SL Pacemakers on August 20, 2025, due to a software issue. This software can prevent the device from initiating Safety Mode in certain conditions. Patients should stop using the device immediately and follow recall instructions.
Boston Scientific recalled 106,536 PROPONENT DR SL MRI pacemakers on August 20, 2025, due to software issues. The recall affects multiple models and aims to prevent safety mode initiation in ambulatory settings. Patients must stop using these devices immediately and follow the manufacturer's instructions.
Boston Scientific recalled 63,851 Proponent DR EL MRI Pacemakers on August 20, 2025. The recall addresses a software issue that may prevent proper device function in certain conditions. Patients must stop using the device and follow manufacturer instructions immediately.
Lannett Company recalled 4,848 bottles of Dextroamphetamine tablets on August 19, 2025. The recall stems from the presence of a foreign tablet in some bottles. This poses a significant risk to consumers who may inadvertently take the incorrect dosage.