Recalls and safety alerts from the FDA, newest first.
Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
July 3, 2026 – Frutas y Hortalizas del Sur S.A., San Carlos, Chile is recalling frozen GreenWise Organic IQF Blueberries 10 oz. Because it may be contaminated with Escherichia coli O145:H28 (E. coli O145).
FRANKLIN, Tenn., (July 2, 2026): Mars Petcare US, Inc. is issuing a voluntary recall for two lots of PEDIGREE® Can High Protein Chopped Chicken & Duck Flavor 13.2oz for dogs.
Gellert Global Group of Elizabeth, NJ is recalling 8.1 oz packages of ALDI Brand Fusia Asian Inspirations Kimchi & Tofu Kimbap because they may contain undeclared fish (tuna). People who have an allergy or severe sensitivity to fish run the risk of serious or life-threatening allergic reaction if t
Terumo has yet to establish a direct causal relationship between the deaths and the delivery system separation issues.
The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
Certain Omnipod Pods may have a tear in the tubing that allows insulin to leak outside the Pod instead of being delivered to the body.
CINCINNATI--(BUSINESS WIRE)--Kao USA Inc. (“Kao USA”) today issued a voluntary recall of select lots of its Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz) in the U.S. and Canada due to the detection of Pluralibacter gergoviae bacteria.
July 01, 2026 EUNHA FISHERIES CO., LTD., Busan, Republic of Korea, is recalling certain Sliced Korean Halibut and Flounder Sashimi products because the accompanying soy sauce and vinegar red pepper paste packets contain wheat, soy, and sesame that were not declared in English on the individual condi
While the company no longer manufactures the radiographic markers, healthcare providers are still advised to monitor patients who have had them implanted.
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg. — Annora Pharma Private Limited · Class II · Ongoing · 31,392 60-count bottles
Presence of Foreign Substance. — Amgen, Inc. · Class II · Ongoing · N/A
Presence of Foreign Substance. — Amgen, Inc. · Class II · Ongoing · 934577 bottles
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. — CareFusion 213, LLC · Class II · Ongoing · N/A
CGMP Deviations — Ajanta Pharma USA Inc · Class II · Ongoing · 3648 bottles
CGMP Deviations — Amgen, Inc. · Class II · Ongoing · N/A
sub potency — Elevate Oral Care · Class II · Ongoing · 8132 6-packs & 2262 2-packs
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Direct Rx · Class II · Ongoing · 263 Bottles
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. — CareFusion 213, LLC · Class II · Ongoing · N/A
Incorrect product formulation: bag did not contain copper and famotidine per label. — Central Admixture Pharmacy Services, Inc. · Class II · Ongoing · One (1) patient-specific TPN prescription
Subpotent Drug — The Harvard Drug Group LLC · Class II · Ongoing · 790 Cartons
Lack of Assurance of Sterility — PReye LLC · Class II · Ongoing · approximate 50 to 60 bottles
Non-Sterility: Due to presence of Aspergillus penicillioides. — CareFusion 213, LLC · Class I · Ongoing · 193,440 applicators