Lupin Pharmaceuticals Inc.: Prednisolone Acetate Ophthalmic Suspension, Usp, 1%

Prednisolone Acetate Eye Drop Recall Summary Lupin Pharmaceuticals is recalling prednisoLONE Acetate Ophthalmic Suspension 1% (an eye drop medication) in 5mL, 10mL, and 15mL bottles distributed nationwide because the product may contain a foreign substance. This is a Class II recall, meaning the product could cause serious adverse health effects. The medication was manufactured by Lupin Limited in India and distributed across all U.S. states and Washington, D.C.

Recalling firm

Lupin Pharmaceuticals Inc.

Product

prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA

Reason

Presence of Foreign Substance

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-04

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S. Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/242c97b2-e34b-40a4-b7a2-090240503335