Lupin Pharmaceuticals recalls 2.5 million bottles of prescription steroid eye drops over contamination
Lupin Pharmaceuticals Inc. recalled more than 2.5 million bottles of its prescription steroid eye drops nationwide in the United States on Thursday. The U.S. Food and Drug Administration classified the voluntary recall as Class II after finding contamination with foreign particulate matter in certain lots, which could cause temporary or medically reversible eye injuries, officials said.
The FDA classified the recall as Class II on June 30, indicating that exposure to the contaminated eye drops could cause temporary or medically reversible eye injuries, such as inflammatory responses, mechanical irritation, corneal injury, or secondary ocular inflammation, officials said. The contamination was identified as foreign particulate matter found in certain lots, based on a single market complaint that prompted a Health Hazard Assessment by the FDA, sources confirmed.
The recall affects 2,530,182 bottles of prednisolone acetate ophthalmic suspension, USP, 1%, in 5 mL, 10 mL, and 15 mL sizes distributed nationwide through pharmacies and healthcare providers, according to FDA enforcement reports and Lupin Pharmaceuticals statements.
Lupin initiated the voluntary recall on June 6, two days after the FDA first flagged the issue on June 4, according to regulatory filings and media reports. The recall remains ongoing, with products actively being removed from the market, and additional notifications expected as the process continues. The affected lots include 132 batches of 5-mL bottles, 36 batches of 10-mL bottles, and 22 batches of 15-mL bottles, with expiration dates ranging from July 31, 2026, to as late as March 31, 2028, according to FDA summaries and Lupin’s recall notice. Only specific lots, including item numbers #1315797 and #1315798, are subject to the recall, not all Lupin eye-drop products, the company clarified.
Patients using the recalled prednisolone acetate drops are advised to stop use immediately and consult their healthcare providers for alternatives, according to FDA guidance. Eye-care providers and pharmacies have been instructed to quarantine affected inventory, discontinue dispensing the product, notify staff and patients, and contact the designated recall coordinator at [email protected] to facilitate removal and replacement of the recalled lots, officials said. Consumers and clinicians are also encouraged to report any adverse events possibly linked to the drops through the FDA’s MedWatch system.
Prednisolone acetate 1% ophthalmic suspension is a corticosteroid widely prescribed for short-term treatment of ocular inflammation caused by allergies, surgery, or injury, sources noted. Unlike some previous eye-drop recalls involving sterility failures, this recall specifically concerns foreign particulate contamination rather than a broad lack of sterility assurance, according to FDA enforcement reports. As of the latest available data, no adverse events or injuries have been formally reported to Lupin or the FDA in connection with this recall, according to coverage summarizing FDA data.
Lupin Pharmaceuticals Inc., a U.S. subsidiary of India-based Lupin Limited, is a global generic drug manufacturer with a significant presence in ophthalmic and cardiovascular medicines. The company has previously conducted voluntary recalls, including a nationwide recall in 2021 of certain irbesartan and irbesartan/hydrochlorothiazide tablet lots due to impurities exceeding acceptable limits. In that case, Lupin cited an abundance of caution and reported no associated illnesses, a posture consistent with its current recall of prednisolone acetate eye drops.
The recall highlights ongoing regulatory scrutiny of generic drug manufacturers and the critical importance of stringent quality-control measures in the production of sterile and semi-sterile ophthalmic products, according to experts cited in FDA and media reports. This action comes amid a broader context of recent eye-drop safety concerns, including a separate voluntary recall of over 3.1 million over-the-counter eye-drop bottles from another manufacturer due to sterility issues. Despite the size of this recall, health authorities emphasize that most unaffected eye-drop products remain safe when obtained from reputable manufacturers and used as directed.
