Articles related to PRODUCT RECALL

The FDA classified a recall of dorzolamide and timolol ophthalmic solution as a Class II event after reports of defective containers, affecting a specific lot used to treat glaucoma and ocular hypertension.

The FDA classified a recall of 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief as a Class II event after the manufacturer identified sterility concerns and potential contamination affecting a single lot.

The FDA issued a Class II recall for an amphetamine-based ADHD medication after a labeling mix-up resulted in immediate-release capsules being packaged as extended release. The recall affects a single lot totaling 1,392 bottles.

The FDA classified the nationwide recall of more than 2.5 million bottles of Lupin’s prednisolone acetate ophthalmic suspension as a Class II recall after reports of a foreign substance in affected products.

Breckenridge Pharmaceutical initiated a voluntary Class II recall of duloxetine delayed-release capsules 60 mg (Lot 241069C, expiration May 31, 2027) on April 21, 2026, following detection of elevated N-nitroso-duloxetine impurity levels attributed to CGMP deviations at the Barcelona manufacturing site, affecting 165,761 bottles distributed nationwide.

Viatris recalled one lot of Xanax XR 3-mg extended-release tablets after failed dissolution testing, with the FDA classifying the action as Class II and reporting no adverse events to date.