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prednisoLONE Acetate Ophthalmic Suspension recall

Lupin Pharmaceuticals Inc. recalled prednisoLONE Acetate Ophthalmic Suspension on July 8, 2026 because of presence of Foreign Substance. It was sold nationwide.

Why it was recalled

Presence of Foreign Substance

What's recalled

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

Quantity: 2,530,182 bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Lupin Pharmaceuticals Inc., Naples, FL
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
U.S. Nationwide
Status
Ongoing
Recall number
D-0655-2026
Source
U.S. Food and Drug Administration

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