1,319 recalls tagged with “fda regulated”.
Gold Star Distribution recalled various feminine hygiene products on December 26, 2025. The recall affects brands including KOTEX and ALWAYS due to potential rodent contamination in their distribution center. Consumers should stop using these products immediately and follow manufacturer instructions for return.
Gold Star Distribution is recalling Pepto Bismol 32-count distributed nationwide after CGMP deviations and unsanitary conditions at its distribution center. The recall cites rodent exposure and unsanitary distribution practices. Consumers and healthcare providers should stop using this product immediately and contact Gold Star Distribution for guidance.
Gold Star Distribution recalls 8oz Ice Gel 12-count sold nationwide after investigators found insanitary conditions at the distributor's facility. A CGMP deviation allowed rodent exposure at the distribution center. Consumers and healthcare providers should stop using this product immediately and await guidance from Gold Star Distribution.
Gold Star Distribution recalls Swan White Clear Alcohol, 50% ABV, 16 oz, 12 count, nationwide. FDA enforcement cites CGMP deviations and insanitary distribution-center conditions including rodent exposure. Stop using the product now and contact the distributor or a healthcare provider for guidance.
Gold Star Distribution recalled PEPCID COMPLETE - 25CT on December 26, 2025 due to insanitary conditions, including rodent exposure. The recall affects all lots distributed by Gold Star and poses a high health risk. Consumers should stop using this product immediately and seek guidance from healthcare providers.
Gold Star Distribution recalls EXCEDRIN 2'S DISP.- 30 CT distributed nationwide in the United States. The recall cites CGMP deviations due to insanitary conditions including rodent exposure at the distribution center. Consumers and healthcare providers should stop using the product immediately and await guidance from Gold Star Distribution.
Gold Star Distribution is recalling petroleum jelly products nationwide in the United States. The recall covers Vaseline brand products and other jelly variants distributed by Gold Star Distribution. The issue stems from CGMP deviations at the distribution center and insanitary conditions due to rodent exposure. Consumers should stop using the affected products immediately and contact the company.
Gold Star Distribution Inc. is recalling Carmex lip balm in 12-count jars and 12-count tubes distributed nationwide in the United States. The recall cites CGMP deviations and insanitary conditions at the distribution center, including rodent exposure. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution for guidance.
Gold Star Distribution Inc. issued a nationwide recall of Colgate and Crest toothpaste on December 26, 2025 after inspectors found insanitary conditions and rodent exposure at its distribution center. The issue stems from CGMP deviations that could contaminate products. Consumers should stop using the affected toothpaste immediately and contact Gold Star Distribution for guidance.
Lucky Ice Cool Mouthwash is being recalled nationwide in the United States. The action targets all lots distributed by Gold Star Distribution due to CGMP deviations and insanitary conditions, including rodent exposure in the distribution center. Consumers should stop using the product immediately and contact Gold Star Distribution for guidance.
Gold Star Distribution is recalling all lots of its Vaporizing Chest Rub, 4 oz, 12-count, UPC 048155903319, distributed nationwide in the United States. The recall, number D-0283-2026, stems from CGMP deviations including insanitary conditions with rodent exposure/activity at the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star
Gold Star Distribution recalled Alka Seltzer on December 26, 2025, due to insanitary conditions at their distribution center. The recall affects Original and Plus Cold & Flu formulations sold in various packaging. Consumers should stop using the product immediately due to potential health risks.
Gold Star Distribution recalls Excedrin Migraine 2's, 25-count bottles distributed nationwide in the United States. CGMP deviations involve insanitary conditions including rodent exposure in the distribution center. Consumers and healthcare providers should stop using the product immediately and contact Gold Star Distribution or their healthcare provider for guidance.
Medline Industries, LP recalled 141,971 suction catheter kits on December 24, 2025. The kits may contain a smaller catheter that can lead to serious respiratory issues. Health providers and patients must stop using the kits immediately to prevent potential harm.
Medline Industries recalled 94 lots of Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters on December 22, 2025. The catheters may contain small particles that pose a risk of serious health issues. Users should stop using the devices immediately and follow manufacturer instructions for return.
Medline Industries recalled 511 reprocessed AcuNav ultrasound catheters on December 22, 2025. These devices may contain small particles that can cause serious health risks such as systemic infections and embolisms. Healthcare providers must stop using the affected devices immediately to prevent potentially life-threatening complications.
Abbott recalled reprocessed steerable diagnostic catheters on December 22, 2025, after discovering potential contamination. The devices may contain small particles that pose risks of systemic infection or embolism. A total of 311 units are affected nationwide.
Bisaf Strep A Self-Test from Altruan GmbH remains active in recall status after the FDA flagged lack of clearance. The Class II medical device was distributed nationwide in the United States. The hazard is lack of FDA clearance. Consumers should stop use immediately and follow manufacturer guidance.
MicroPort Orthopedics recalled 91 units of the HIPTURN Fem Head Trial 36mm Reusable device on December 19, 2025. The recall follows the lack of FDA premarket authorization for distribution in the United States. The affected devices were distributed across multiple states and several countries, posing a potential health risk to patients and healthcare providers.
Siemens Medical Solutions USA, Inc. recalled 88 units of NAEOTOM Alpha software applications on December 19, 2025. The applications lack FDA 510(k) clearance, posing potential risks to patient safety. Healthcare providers must stop using the software immediately and follow the manufacturer's instructions.