689 recalls tagged with “fda regulated”.
Meclizine Hydrochloride Tablets distributed nationwide by Amerisource Health Services LLC are being recalled. The two affected NDCs are 60687-775-65 and 60687-775-11. The recall is due to failed tablet specifications. Stop using the product and contact a healthcare provider for guidance immediately.
Pocas International recalled 517 cases of Popping Boba RTD Mango Passion Fruit Green Tea distributed to NY, VA, FL, MA, TX, LA, UT, CA and Canada. A packaging integrity issue may compromise product quality. Consumers who purchased it should not consume the beverage and should contact Pocas International for refund or replacement via email.
Pocas International Corp. recalls 148 cases of POPPING BOBA RTD Mixed Berry Hibiscus Tea distributed to New York, Virginia, Florida, Massachusetts, Texas, Louisiana, Utah, California and Canada. A packaging integrity issue may compromise product quality. Consumers who purchased should not consume it and should contact Pocas International for refund or replacement information via email.
Western Mixers Produce & Nuts recalled 384 cases of First Street Chilli Spanish Peanuts after a glass fragment was found inside sealed containers. The recall covers two consignees and 53 retail locations nationwide. Consumers should not eat the product and should email the company for refund or replacement.
Lone Star Dairy Products LLC issued an active recall of 1.79 million pounds of spray dried dairy powder sold in the United States after Salmonella spp. was identified in finished product testing. The affected product is packaged in 25 kg bags or 1 metric ton totes. Consumers should not consume the product and should contact Lone Star Dairy Products LLC for refund or replacement information via e‑m
Nuts.com recalled 10,190 pounds of Espresso Malted Milk Balls distributed nationwide in the United States. The recall cites undeclared wheat and soy allergens from soy lecithin in the ingredient statement. Consumers who bought this product should not consume it and should contact Nuts.com for a refund or replacement via email.
South Florida Food, LLC recalled 1,500 Pan de Bono Cheese Bread units sold through Florida retailers after undeclared soy was identified. The recall is Class II. Consumers should not consume the product and should contact South Florida Food, LLC for refund or replacement.
Distribuidora de Alimentos Sendero LLC recalled 500 Doraditas de Azucar sold in Texas. The products are missing Wheat and Soy allergen labeling on the package. Consumers should not eat them and should contact Sendero LLC for refund or replacement.
Distribuidora de Alimentos Sendero LLC recalls 2,500 Gorditas de Azucar and Doraditas distributed in Texas. The recall is due to missing Wheat and Soy allergens on the label. Consumers should stop using it and contact Sendero LLC for refund or replacement.
JFE FRANCHISING INC recalled two dumpling products sold at retailers nationwide: Dumpling Vegetable 4.5 oz (UPC 011110658067) and Loaded Dumpling Vegetable 5.7 oz (UPC 011110696953) due to a glass contamination risk. The recall is Class II with a high hazard level. Consumers should not eat the dumplings and should contact JFE FRANCHISING INC by email for refund or replacement.
Philips Medical Systems Nederland B.V. recalled 3,552 Vue Motion V12 devices worldwide, including the United States. The recall is due to a potential that mis-ordered frames during dynamic cine runs may display out of sequence. Stop using the device and follow the recall instructions provided by the manufacturer.
JFE Franchising Inc. recalls Dumpling Party Tray products and a Cheetos Flamin Hot Loaded Dumpling item after glass fragments were found in the trays. The FDA enforcement report lists glass as the foreign object hazard. Consumers should not eat these products and should seek refunds or replacements via email.
Koven Technology recalled 34 BiDop 3 Pocket Dopplers with BT2M20S8C fetal probes nationwide after regulators found the fetal indication on the labeling was not cleared under 510(k). The defect is labeling that misrepresents fetal use. Healthcare providers and patients should stop using the devices and follow recall instructions from the manufacturer.
Ajinomoto Foods North America recalled Trader Joe's Vegetable Fried Rice sold at Trader Joe's nationwide after glass fragments were found in the product. The contamination involves glass shards ranging from 1 to 3 cm long and 2 to 4 mm wide. Consumers should not eat this product and should contact Ajinomoto Foods North America for refunds or replacements.
Ajinomoto Foods North America recalls Ajinomoto Golden Tiger Vegetable Fried Rice sold at multiple retailers nationwide. Glass fragments measuring 1-3 cm long and 2-4 mm wide have been found in frozen rice. Consumers should not eat the product and should contact Ajinomoto for refunds or replacements.
Philips Medical Systems Nederland recalled 5,167 Azurion 7 M20 X-ray imaging systems sold to healthcare facilities in the U.S. and internationally. The wired foot switch can fail to initiate imaging or produce intermittent imaging. Hospitals and clinics should stop using the device and follow recall instructions from Philips, with notification by letter to affected parties.
Philips Medical Systems Nederland B.V. recalled 5,084 ALLURA Xper FD20 imaging systems sold nationwide and internationally after finding that the wired foot switch may fail to initiate X-ray imaging or perform intermittently. The defect can delay or interrupt imaging during patient care. Healthcare facilities should stop using the devices and follow the manufacturer’s recall instructions.
Philips Medical Systems Nederland B.V. recalls 2 ALLURA Xper FD10 OR Tables after reports that X-ray imaging may not start or may delay when using the wired foot switch. The defect could affect patients during imaging procedures. Healthcare providers should stop using the device and follow recall instructions from the manufacturer.
KC Pharmaceuticals recalled 182,424 Sterile Eye Drops AC bottles sold nationwide under multiple brands including Quality Choice Eye Drops Irritation Relief and Goodsense Ultra Lubricant Eye Drops. The recall cites a lack of assurance of sterility. Consumers should stop using the product immediately and contact KC Pharmaceuticals for guidance.
Philips recalled 112 ALLURA Xper FD10/10 imaging systems nationwide in the United States and internationally after reports that X-ray imaging may not start or may intermittently stop when using the wired foot switch. The defect affects system codes 722005, 722011, and 722027. Healthcare providers should stop using the devices and follow Philips recall instructions.