State
72,984 recalls have nationwide distribution and so reach Maine. 3,894 additional recalls listed Maine specifically in their distribution scope.
Of the 3,894 recalls naming Maine we have scored against our rubric, 468 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 791 (20%) are Severe.
Which agencies issued them
These figures cover only the 3,894 recalls whose distribution notice names Maine specifically. The 72,984 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Glenmark Carvedilol Tablets USP, 12.5 mg, lot 19243202, are recalled nationwide because N-Nitroso Carvedilol I impurity was found above the current Acceptable Intake level. 6,432 bottles are affected.
La Michoacana Bubble Gum Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 12,163 units are affected.
Carefree Surgical Specialties Robotic/Laparoscopy Kittner Rolls Gauze, catalog 15505/25 lot 1645, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 500 units are affected.
Custom Waste Management Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 858 units affected.
Carefree Surgical Specialties Kittner + Tail Large roll gauzes are being recalled for product contamination with biological foreign matter that could compromise sterility, and an incorrect quantity of gauze in sterile packaging.
Glenmark Carvedilol Tablets USP, 25 mg, in 500-tablet cartons are recalled nationwide after N-Nitroso Carvedilol Impurity-1 was found above the FDA-recommended limit. 14,976 bottles are affected.
Glenmark Carvedilol Tablets USP, 3.125 mg, in 100- and 500-count bottles are recalled nationwide because N-Nitroso Carvedilol I impurity exceeded the current Acceptable Intake level. 44,328 bottles are affected.
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 65 40-S, lot 8-4528, are recalled because the screws may be incorrectly labeled. 16 units are affected.
Carvedilol Tablets USP 25 mg from Glenmark are being recalled because of the presence of a nitrosamine, N-Nitroso Carvedilol I, above the current Acceptable Intake Level. 4,800 bottles affected.
Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.
La Michoacana Strawberry Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 33,105 units are affected.
Insightra Ultra IABP Catheter Kits are being recalled because the device carries indications and compatibility claims not reviewed by the FDA, and its instructions are inconsistent with product training.
Theophylline extended-release tablets 400 mg from Glenmark are being recalled because dissolution results at the long-term shelf life stability interval did not comply with L3 stage criteria. 22,656 bottles affected.
HemosIL LMW Heparin Controls, part number 0020300200, are recalled after complaints of lower than expected quality control recovery. 41,824 units are affected.
Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.
Lithium Orotate 5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide for failing to meet its labeled potency, following a recall by the ingredient supplier.
Bartels ELISA Legionella Urinary Antigen kits are being recalled because two lots have the potential to contain particulate matter. 968 kits are affected.
Lithium Orotate 20 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
Lithium Orotate 10 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
Lithium Orotate 2.5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency. The action follows a recall by the ingredient supplier.
Prosthesis Head B, 28 mm with 7 mm neck length, is being recalled because of inconsistent size terminology and colour coding used on the labeling. 46 units are affected.
Zvu Anorectal Manometry Procedure Kits are being recalled because the outer kit label carries an incorrect expiration date, with the manufacturing date used in its place. 8 kits are affected.
Lithium Orotate 1 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
Belsomra (suvorexant) 10 mg tablets are being recalled because of failed dissolution specifications, with potential for delayed release of the drug and delayed onset of sleep. 51,320 cartons affected.
BD is recalling 6,076 Pyxis MedBank and MedBank Mini automated dispensing cabinets after reports of delayed access to medication caused by the override and Add Item workflow.