Recall: D-0655-2026

Class II - Potentially Harmful

Class IIClassification

2026-06-04Initiated

OngoingStatus

Lupin Pharmaceuticals Inc.Firm

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

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.