689 recalls tagged with “fda regulated”.
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.
LotFancy recalled 91,366 urinary tract infection test strips on November 22, 2025. The strips may produce false results, risking inappropriate medical intervention. Affected products include various models sold nationwide in states like 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.
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 Menopause Test Cassettes on November 22, 2025. The recall follows reports that the devices can produce false or inaccurate results, potentially leading to inappropriate medical interventions. Customers in Texas, Georgia, and California should stop using the test immediately and follow recall instructions.
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.
Glenmark Pharmaceuticals recalled over 11,000 bottles of Bisoprolol Fumarate and Hydrochlorothiazide Tablets on November 21, 2025. Testing revealed traces of ezetimibe, posing a health risk. Consumers should stop using the product immediately and contact their healthcare provider.
Ambriola Co., Inc. recalled 6,632 units of Grated Pecorino Romano cheese on November 21, 2025. The product tested positive for Listeria Monocytogenes, a dangerous bacteria that can cause serious illness. Consumers should not consume the affected product and should seek refunds or replacements.
Ambriola Co., Inc. recalled 1,015 bags of Sam's Pecorino Romano grated cheese on November 21, 2025. The product tested positive for Listeria Monocytogenes, a harmful bacteria. Consumers should not consume the product and seek a refund or replacement 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.
Ambriola Co., Inc. recalled 45 bags of Pinna Grated Pecorino Romano on November 21, 2025, after Listeria Monocytogenes was detected. The recall affects products distributed in 17 states including California and Texas. Consumers should not consume the recalled product and should seek refunds or replacements.
A New Life Herbs, LLC recalled 144 bottles of Chaga Mushroom Herbal Supplement on November 20, 2025. The product is misbranded due to unapproved drug claims and lack of a Supplement Facts label. Consumers should stop using the product immediately and seek a refund.
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, LLC recalled 23 bottles of its Baby Allergy Herbal Supplement on November 20, 2025. The recall follows unapproved drug claims and absence of a Supplement Facts label on the product. Consumers should not consume the supplement and should seek refunds immediately.
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.
Karabetian Import and Distribution recalled 338 boxes of Zimi Puff Pastry on November 18, 2025. The recall was initiated due to the presence of partially hydrogenated oils, which are not permitted in foods exported to the U.S. Consumers should not consume the product and seek a refund or replacement.
Sheathing Technologies recalled 12 units of its ultrasound probe covers on November 17, 2025, due to potential contamination risks. The non-sterile vaginal and rectal covers may have defects that pose an infection risk during use. Consumers should stop using the product immediately and follow the manufacturer's instructions.
Prime Food Processing recalled 2,243 cases of Lava Bun with Green Tea Flavor on November 16, 2025. The product does not declare milk in its ingredient statement, posing a risk to consumers with milk allergies. The recall affects 16 states including California, Texas, and Florida.