689 recalls tagged with “fda regulated”.
Inpeco S.A. recalled eight units of its FlexLab (FLX) Potassium Test System on September 3, 2025. The system's Sample Integrity Module may produce erroneous results due to unverified functions. Healthcare providers must stop using the device immediately and follow the manufacturer's instructions.
Philips Medical Systems Nederland B.V. recalled 300 Allura Xper FD20/15 devices on September 3, 2025. The BIOS battery may deplete too quickly, halting system start-up. Users may not receive any warning before the battery fails.
Major Pharmaceuticals recalled Sulfamethoxazole and Trimethoprim tablets on September 2, 2025, due to contamination concerns. A foreign substance was found in the packaging material, although the tablets themselves remain unaffected. Consumers should stop using the product immediately and consult healthcare providers.
Fagron Compounding Services recalled 109,320 syringes of bevacizumab (Avastin) on August 29, 2025. The recall follows a lack of assurance of sterility, posing a high health risk. Consumers and healthcare providers should stop using the product immediately.
Fresenius Medical Care Holdings recalled over 172 million dialyzers on August 29, 2025. The recall affects models with a new cap design that may not securely attach. Healthcare providers and patients must stop using these devices immediately.
Herbal Creations recalls 19,425 kilograms of bulk colostrum powder distributed to 30 US customers after a milk allergen labeling error. The product label does not declare milk as an allergen. Consumers who purchased this product should not consume it and should contact Herbal Creations USA for refund or replacement.
Baxter Healthcare recalled 2,304 Clearlink System Extension Sets on August 29, 2025, due to potential leakage. The recall affects IV sets distributed nationwide across multiple states. Healthcare providers and patients should stop using the device immediately.
Granules Pharmaceuticals Inc. recalled 11,895 bottles of extended-release capsules on August 28, 2025. The capsules failed impurities and degradation specifications. Consumers should stop using the product immediately, as it could pose health risks.
Granules Pharmaceuticals Inc. recalled 3,384 bottles of amphetamine capsules on August 28, 2025. The recall follows a failure to meet impurities and degradation specifications. Consumers should stop using this product immediately and consult healthcare providers.
Ascend Laboratories, LLC recalled 2,256 bottles of Aripiprazole Tablets on August 28, 2025. The recall followed reports that the drug may be superpotent, posing serious health risks. Consumers should stop using the product immediately and consult healthcare providers.
Green Lumber Holdings recalled its Natural Fuel For Men capsules on August 28, 2025. The FDA found the capsules contain tadalafil, a prescription ingredient not approved for this product. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Middlefield Original Cheese Cooperative recalled 364 cases of Pepper Jack Cheese on August 27, 2025. The recall follows potential contamination with Listeria monocytogenes. Consumers should not eat the product and seek refunds or replacements.
Middlefield Original Cheese Cooperative recalled 364 cases of Swiss cheese on August 27, 2025. The recall stems from potential contamination with Listeria monocytogenes. Consumers should not consume the product and seek refunds immediately.
Middlefield Original Cheese Cooperative recalled 7,455 pounds of shredded mozzarella cheese on August 27, 2025. The product may contain Listeria monocytogenes, which can cause serious illness. Consumers should not consume the cheese and seek refunds or replacements.
American Health Packaging recalled 873 cartons of Chlorpromazine Hydrochloride Tablets on August 27, 2025. The recall stems from the presence of a micro-organism in packaging material. No micro-organisms were found on the tablets themselves.
Middlefield Original Cheese Co-op recalled 364 cases of Organic Gouda Cheese on August 27, 2025. The recall follows potential contamination with Listeria monocytogenes, which can cause serious illness. Consumers should not eat the cheese and seek refunds or replacements.
Extract Labs recalled 19,810 units of Blue Razz 20mg Gummies on August 26, 2025. The recall follows concerns about potential peanut protein cross-contact. Consumers should not consume the product and should seek a refund.
B. Braun Medical Inc. recalled 16,228 bags of Sodium Chloride Irrigation Solution on August 26, 2025. The recall stems from a lack of assurance of sterility, posing a high risk of contamination. Consumers and healthcare providers should stop using the product immediately and seek guidance from B. Braun or their healthcare provider.
B. Braun Medical Inc. recalled 26,316 bags of Sterile Water for Injection on August 26, 2025. The recall affects the 3000 mL product due to potential fluid leakage from a misaligned port. Consumers should stop using the product immediately and seek guidance from healthcare providers.
Country Eggs, LLC recalled 81,542 dozen shell eggs on August 26, 2025. The eggs may be contaminated with salmonella, posing a serious health risk. Consumers should not eat these products.