Class IIOngoing
prednisoLONE Acetate Ophthalmic Suspension recall
FDA recall D-0655-2026 · initiated Jun 4, 2026
By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Jul 8, 2026How we research
Lupin Pharmaceuticals Inc. recalled prednisoLONE Acetate Ophthalmic Suspension in Jun 2026 — an FDA Class II recall (D-0655-2026) because Presence of Foreign Substance.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Substance
Details
- 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
- Recalling company
- Lupin Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Jun 4, 2026
- FDA report date
- Jul 8, 2026
This recall is linked to a product we cover: Prednisolone Acetate →
Frequently asked
- Was prednisoLONE Acetate Ophthalmic Suspension recalled?
- Lupin Pharmaceuticals Inc. recalled prednisoLONE Acetate Ophthalmic Suspension in Jun 2026 — an FDA Class II recall (D-0655-2026) because Presence of Foreign Substance. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was prednisoLONE Acetate Ophthalmic Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0655-2026 was: Presence of Foreign Substance
- Is a recalled prednisoLONE Acetate Ophthalmic Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of prednisoLONE Acetate Ophthalmic Suspension are affected?
- Distribution: U.S. Nationwide. The affected lot numbers and expiration dates are listed in the official FDA enforcement record for recall D-0655-2026, initiated Jun 2026.