FDA RECALL: Prednisolone Acetate Eye Drops Pulled in Nationwide Class II Recall

More than 2.5 million prescription eye‑drop bottles recalled for foreign‑substance contamination.

A nationwide Class II recall has been issued for 2,530,182 bottles of prednisolone acetate ophthalmic suspension 1%, a prescription steroid eye medication used to treat inflammation following eye surgery and in conditions such as uveitis. The recall was initiated by manufacturer Lupin Limited and formally classified by the FDA on June 30, 2026.

According to the FDA, the affected bottles may contain a foreign substance, prompting removal of multiple product sizes  5‑mL, 10‑mL, and 15‑mL  across extensive lot numbers with expiration dates running into 2027.

Patients are advised to check their bottle’s NDC and lot number against the FDA recall list and contact their pharmacist or prescriber for next steps. The FDA cautions patients not to stop using prednisolone acetate abruptly without medical direction, as sudden discontinuation can worsen inflammation.

This recall is new and separate from the OTC eye‑drop sterility recalls previously covered by Coastal Carolina News. The current action involves a prescription‑only medication, a different manufacturer, and a foreign‑substance contamination issue rather than sterility failures.

The recall remains active as FDA monitors product removal and safety reporting.