1,319 recalls tagged with “fda regulated”.
GE Healthcare recalled Omnipaque iohexol injection, 300 mg/mL, distributed nationwide in the United States. The Class II recall covers 866,570 vials due to particulate matter. Healthcare providers should stop use and contact GE Healthcare Ireland Limited for guidance.
GE Healthcare recalled Omnipaque iohexol injection after discovery of particulate matter. The recall covers 306,810 vials distributed nationwide in the United States. WHS: Distributed by GE Healthcare Inc., Marlborough, MA. Consumers should stop use and consult a healthcare provider for guidance.
Fagron Compounding Services recalled 5,140 bags of norepinephrine Bitartrate injection due to lack of sterility assurance. A blue Break-Off-Part could detach from the administration port. The recall covers nationwide distribution in the U.S. Consumers should stop use and contact providers for guidance.
Aisstxoer adult bicycle helmets sold on Amazon by YXTDZ Store are being recalled. The helmets fail to meet mandatory safety standards for impact attenuation and stability, creating a serious head-injury risk. Stop using the recalled helmet now and contact YXTDZ Store for a full refund; destroy the helmet and email a photo to yxtdzamz@126.com.
Teva-affiliated Clonidine Transdermal System recalls 113,943 cartons after CGMP deviations. Unapproved raw material prompts recall. Stop use immediately and contact Teva or a healthcare provider for guidance.
Amneal Pharmaceuticals is recalling 29,542 bottles of TRAMADOL HYDROCHLORIDE tablets distributed nationwide in the United States. The recall cites a failed impurity specification for N-nitroso-desmethyl-tramadol (NDSRI) at the 24‑month stability interval. Consumers and healthcare providers should stop using the product immediately and contact Amneal for guidance.
Riverence Provisions LLC recalls 3,672 units of Smoked Trout Dip sold frozen in cases distributed to eight states over milk allergen labeling. The recall is active as of April 15, 2026. Do not consume the product. Contact Riverence Provisions for refund or replacement.
Teva Pharmaceuticals recalled 124,054 cartons of Clonidine Transdermal System due to CGMP deviations from an unapproved raw material. The recall affects products sold in the United States. Consumers should stop using the product immediately and consult a healthcare provider for guidance.
Teva Pharmaceuticals recalled 21,930 cartons of Octreotide Acetate for Injectable Suspension distributed nationwide in the United States. The recall stems from lack of assurance of sterility identified during an FDA inspection at the contract manufacturer. Healthcare providers and patients should stop using this product immediately and contact Teva or a physician for guidance.
Chiesi USA recalled 7,235 Curosurf vials distributed nationwide to hospitals and clinics. The recall cites a lack of assurance of sterility. Healthcare providers should stop using the product immediately and contact Chiesi USA for guidance.
Straumann USA recalled 13 Custom Abutment Ti RC units distributed worldwide, including the United States and Canada. A TAN material was misidentified as Titanium Ti Gr4 D during manufacturing, causing RC Titanium abutments to be made from TAN material. Clinics and patients should stop using the devices immediately and follow recall instructions from Straumann USA or their healthcare providers.
Straumann USA LLC recalls 7 Custom Abutment AS Ti for Straumann RC. The recall follows a material mix-up during manufacturing. A TAN material bar was incorrectly identified as Titanium Bar Ti Gr4 D, causing RC Titanium abutments to be made with TAN material. Stop using the device and contact Straumann for instructions immediately.
Teva Pharmaceuticals USA recalled 19,869 cartons of Octreotide Acetate for Injectable Suspension nationwide in the United States after FDA inspection flagged lack of assurance of sterility at the contract manufacturer. The FDA cited quality system deficiencies at Pharmathen International S.A. in Greece. Healthcare providers and patients should stop using the product immediately and contact Teva or
Teva Pharmaceuticals recalled 1,897 cartons of Octreotide Acetate for Injectable Suspension distributed nationwide in the USA after an FDA inspection flagged sterility concerns. The recall is due to lack of assurance of sterility from the contract manufacturer. Consumers and healthcare providers should stop using the product immediately and contact Teva for guidance.
Xanax XR extended-release alprazolam recall issued March 17, 2026 remains active. Viatris Specialty LLC distributes the drug nationwide in the United States. The issue is failed dissolution specifications. Patients and healthcare providers should stop using the product immediately and follow the recall instructions for guidance.
POCAS INTERNATIONAL recalled 425 cases of POPPING BOBA RTD Strawberry Dragon F/OOLONG Tea distributed in NY, VA, FL, MA, TX, LA, UT, CA and Canada. The recall cites a packaging integrity issue that may compromise product quality. Consumers should not consume the product and should contact Pocas International by email for refunds or replacements.
Lucerne recalled 12,222 tubs of 2% cottage cheese sold at Albertsons stores after metal fragments were found in packaging. The object is a curled stainless steel spring and could end up in the product. Stop using the product and contact Albertsons Companies LLC for a refund or replacement.
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.