FDA Recalls 2.5 Million Lupin Eye-Drop Bottles Over Foreign Matter
Updated
Updated · Eyes On Eyecare · Jul 9
FDA Recalls 2.5 Million Lupin Eye-Drop Bottles Over Foreign Matter
3 articles · Updated · Eyes On Eyecare · Jul 9
Summary
More than 2.53 million bottles of Lupin’s prednisolone acetate ophthalmic suspension were recalled nationwide after the FDA classified the action as Class II following a June 4 voluntary retail-level recall.
A single market complaint alleging foreign particulate matter triggered the recall, and the FDA said the contamination could cause mechanical irritation, corneal injury, inflammatory responses and secondary ocular inflammation.
The affected prescription steroid eye drops—approved in August 2024 as a generic version of AbbVie’s Pred Forte—come in 5 mL, 10 mL and 15 mL bottles with expiration dates from July 31, 2026, to March 31, 2028.
Hilco Vision, one confirmed distributor, told eyecare providers to stop using and quarantine affected lots, notify customers and contact the company if recalled product had been dispensed to patients.
No additional infections or contamination reports were cited beyond the initial complaint; Class II recalls indicate potentially temporary or medically reversible harm, with a remote chance of serious consequences.