1,320 recalls tagged with “fda regulated”.
Advanced Bionics recalled 2 Sky CI M90 behind-the-ear sound processors on 2025-11-27. The packaging label does not match the included product. Consumers should stop using the device and follow manufacturer instructions.
Medline Industries recalled 11,173 IV administration kits on November 26, 2025. The kits contain B. Braun IV Administration Sets and Pump Administration Sets with faulty check valves. These valves may become stuck, posing a high hazard to patients.
Towa Pharmaceuticals recalled 3,397 bottles of Duloxetine Delayed-Release Capsules on November 24, 2025. The recall stems from CGMP deviations resulting in N-nitroso-duloxetine levels exceeding FDA limits. Consumers must stop using the product immediately.
Vivoo recalled 3,000 vaginal pH tests on November 22, 2025. The tests may cause false results leading to inappropriate medical interventions. The products were distributed nationwide, including Texas, Georgia, and California.
Changchun Wancheng Bio-Electron Co. recalled 1,000 male fertility sperm tests on November 22, 2025. The tests were distributed without proper FDA clearance and may yield inaccurate results. This could lead to inappropriate medical interventions by users.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Product tested positive for Listeria Monocytogenes.
Lotus Mom Corporation recalled 56 units of its 9-inch aluminum saucepan on November 21, 2025. The product may contain leachable lead, posing serious health risks. Consumers should not use the saucepan and seek refunds immediately.
Fresenius Kabi USA recalled 30 units of the Ivenix Infusion System LVP Software on November 21, 2025. The recall addresses concerns related to programming instructions for LVP duration. Patients and healthcare providers must stop using the device immediately.
Product tested positive for Listeria Monocytogenes.
Product tested positive for Listeria Monocytogenes.
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label
A New Life Herbs recalled Sinus Cap Herbal Supplement on November 20, 2025, due to unapproved drug claims. The product lacks a Supplement Facts label, which misbrands it. Consumers should not consume the product and seek refunds or replacements.
A New Life Herbs recalled 275 bottles of Pain Away Herbal Supplement on November 20, 2025. The product contains unapproved drug claims and lacks a Supplement Facts label. Consumers should not consume this product and seek refunds.
GUSTO GROUP recalled 7 cases of DPA161 Shrimp Paste on November 19, 2025. Testing revealed elevated lead levels in the product. Consumers in Iowa and New Jersey should not consume this product.