Warning
Lupin Pharmaceuticals Inc. Recalls prednisoLONE Acetate Ophthalmic Suspension
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0655-2026Drug / Pharmaceutical
Lupin Pharmaceuticals Inc. Recalls prednisoLONE Acetate Ophthalmic Suspension
Lupin Pharmaceuticals Inc. · Class II — Moderate Risk
Product Description
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 for Recall
Presence of Foreign Substance
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
U.S. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Lupin Pharmaceuticals Inc. initiated the recall on June 4, 2026 affecting 2,530,182 bottles. Presence of Foreign Substance. The product was distributed in U.S. Nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Lupin Pharmaceuticals Inc. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.