Drugs
Class II
Ongoing
Reported Sep 2, 2026
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc....
Firm: Hikma Pharmaceuticals USA INC.
Reason: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
openFDA source record
Food
Class II
Ongoing
Reported Sep 2, 2026
Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Firm: Dreyer's Grand Ice Cream Inc.
Reason: Foreign object: products may contain glass pieces
openFDA source record
Food
Class II
Ongoing
Reported Sep 2, 2026
Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Firm: Dreyer's Grand Ice Cream Inc.
Reason: Foreign object: products may contain glass pieces
openFDA source record
Food
Class II
Ongoing
Reported Sep 2, 2026
Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Firm: Dreyer's Grand Ice Cream Inc.
Reason: Foreign object: products may contain glass pieces
openFDA source record
Food
Class II
Ongoing
Reported Sep 2, 2026
Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Firm: Dreyer's Grand Ice Cream Inc.
Reason: Foreign object: products may contain glass pieces
openFDA source record
Devices
Class II
Ongoing
Reported Sep 2, 2026
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Firm: Olympus Corporation of the Americas
Reason: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
openFDA source record