Timolol Maleate Ophthalmic Solution Recall Due to Defective Container

FDC Limited, in coordination with the US Food and Drug Administration (FDA), has issued a voluntary recall of Timolol Maleate Ophthalmic Solution USP, 0.5% (5mL bottles, Rx only). The recall affects lot #083J033 (expiration date 09/2025) and involves 118 104 bottles distributed by Rising Pharmaceuticals Inc, New Jersey. The reason for the recall stems from a defective container—specifically, the spike of the cap has become lodged in the bottle's nozzle, preventing users from dispensing the medication. As of now, no press release has been issued regarding this recall.

The FDA has classified this as a Class II recall, indicating that while the defect may not cause immediate harm, it could lead to temporary or medically reversible adverse health consequences. The recall was voluntarily initiated by FDC Limited on January 23, 2025, with the agency officially classifying it on January 31, 2025. The affected product was distributed to a single US distributor in New Jersey, and customers were notified via letter. The recall remains ongoing as efforts continue to remove the impacted bottles from circulation.

Timolol maleate ophthalmic solution is a beta-blocker primarily prescribed for the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. By reducing aqueous humor production, the medication helps lower intraocular pressure, thereby reducing the risk of optic nerve damage and vision loss. Pharmacists should advise patients using this product to check their bottles and contact their provider or Rising Pharmaceuticals for guidance on obtaining an unaffected replacement.