health 1 min read

FDA Recalls Over 2.5 Million Prescription Eye Drop Bottles Nationwide

Lupin Pharmaceuticals recalls 2.5M+ bottles of Prednisolone eye drops due to potential foreign substance. The FDA Class II recall affects multiple bottle sizes.

2026-07-10T09:20:58.608Z

FDA Recalls Over 2.5 Million Prescription Eye Drop Bottles Nationwide

The FDA has issued a nationwide recall for over 2.5 million bottles of prescription eye drops. The recall, classified as Class II by the agency, applies to Prednisolone Acetate Ophthalmic Suspension, 1%.

The affected products were manufactured by Lupin Pharmaceuticals. The recall was initiated in June due to the potential presence of a foreign substance in the medication. A Class II recall indicates the product could cause temporary or reversible health issues.

The recalled eye drops are used to treat non-infectious eye inflammation and allergies. The FDA's report specifies three bottle sizes: 5 mL (NDC 70748-332-02), 10 mL (NDC 70748-332-03), and 15 mL (NDC 70748-332-04). Consumers and pharmacies should stop using the affected product immediately.

Topics Prednisolone Lupin Pharmaceuticals FDA eye drop recall ophthalmic suspension