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
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Lots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026; HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, HA01048, Expires: 8/31/2026; HA01120, HA01137, HA01129, HA01138, HA01133, Expires: 9/30/2026; HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, HA01220, Expires: 10/31/2026; HA01236, HA01238, HA01240, HA01244, HA01246, HA01248, HA01261, HA01263, HA01265, HA01267, HA01278, HA01280, HA01282, HA01284, HA01288, HA01290, HA01292, HA01298, Expires: 11/30/2026; HB00002, HB00004, HB00006, HB00017, HB00019, HB00021, HB00023, HB00025, HB00031, HB00033, HB00035, HB00037, HB00039, HB00041, HB00043, Expires: 12/31/2026; HB00049, HB00051, HB00076, HB00078, HB00080, HB00082, HB00084, Expires: 1/31/2027; HB00128, HB00130, HB00132, HB00134, HB00157, HB00159, HB00161, HB00196, HB00198, HB00200, Expires: 2/28/2027; HB00224, HB00226, HB00228, HB00230, HB00240, HB00242, Expires: 3/31/2027; HB00416, HB00417, HB00419, HB00439, HB00441, HB00443, HB00463, HB00465, Expires: 5/31/2027; HB00561, Expires: 6/30/2027; HB00569, HB00657, HB00659, HB00663, HB00671, HB00673, HB00675, HB00677, HB00679, Expires: 10/31/2027; HB00747, HB00749, HB00751, HB00753, Expires: 11/30/2027; HB00761, HB00763, HB00765, HB00783, HB00785, HC00002, HC00004, HC00006, HC00018, HC00020, HC00028, Expires: 12/31/2027; HC00030, HC00032, Expires: 1/31/2028; HC00056, HC00058, HC00062, HC00064, HC00073, HC00075, HC00079, HC00081, HC00083, Expires: 2/29/2028; HC00091, Expires: 3/31/2028; b) HA00945, HA00947, HA00949, Expires: 7/31/2026; HA01160, HA01162, HA01164, Expires: 10/31/2026; HA01234, HA01300, HA01302, Expires: 11/30/2026; HB00053, HB00055, HB00057, Expires: 1/31/2027; HB00107, HB00109, HB00111, HB00151, HB00153, HB00155, Expires: 2/28/2027; HB00386, HB00388, HB00390, HB00445, HB00447, Expires: 5/31/2027; HB00549, HB00551, HB00553, HB00555, Expires: 6/30/2027; HB00700, HB00702, Expires: 10/31/2027; HB00771, Expires: 11/30/2027; HC00008, HC00010, Expires: 12/31/2027; HC00034, HC00038, HC00054, HC00060, Expires: 1/31/2028; c) HA00951, HA00953, HA00955, Expires: 7/31/2026; HA01188, HA01190, HA01192, Expires: 10/31/2026; HA01304, Expires: 11/30/2026; HB00113, HB00115, Expires: 1/31/2027; HB00166, HB00168, Expires: 2/28/2027; HB00392, HB00394, HB00396, Expires:5/31/2027; HB00545, HB00547, Expires: 6/30/2027; HB00704, Expires: 10/31/2027; HB00773, Expires: 11/30/2027; HC00012, HC00014, Expires: 12/31/2027; HC00066, HC00068, Expires: 2/29/2028.
Quantity recalled: 2,530,182 bottles
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?
- Distributed: U.S. Nationwide. The recall covers these lots — Lots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026; HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, HA01048, Expires: 8/31/2026; HA01120, HA01137, HA01129, HA01138, HA01133, Expires: 9/30/2026; HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, …. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0655-2026.