Lupin Pharmaceuticals is recalling over 2.5 million bottles of prednisolone acetate ophthalmic solution 1% after the FDA flagged the presence of a foreign substance. The Class II recall covers multiple bottle sizes with expiration dates stretching to March 2028. This follows a separate recall of more than 3 million eye drop bottles from K.C. Pharmaceuticals earlier this year.
Lupin Pharmaceuticals is pulling more than 2.5 million bottles of prednisolone acetate ophthalmic solution 1% — a steroid eye drop used to reduce inflammation — from the U.S. market. The FDA-flagged recall, officially issued on June 4, cites the "presence of foreign substance" as the cause. The affected bottles (5 mL, 10 mL, and 15 mL sizes) were manufactured at Lupin Ltd.'s facility in Pithampur, India, and distributed nationwide, with expiration dates ranging from July 2026 through March 2028.
The recall is classified as Class II, meaning the contamination could cause temporary or reversible adverse health effects — serious, but not immediately life-threatening. This isn't Lupin's first eye drop recall; the company previously pulled drops used to treat bacterial conjunctivitis back in 2019.
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Why it matters: Eye drop recalls have been a recurring concern in recent years, highlighting the importance of supply chain oversight — especially for products manufactured overseas. Patients and providers should check lot numbers against the FDA recall notice and discontinue use of affected bottles immediately.
