FDA recall D-0655-2026

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 for recall

Presence of Foreign Substance

Distribution

U.S. Nationwide

Key facts

Status

Ongoing

Initiation date

2026-06-04

Report date

2026-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2026