CLASS II ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report

prednisoLONE Acetate Ophthalmic Suspension recalled

Lupin Pharmaceuticals is recalling prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, distributed nationwide in the US. The recall was initiated on 4 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 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.

NDC70748-332

Quantity recalled2,530,182 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0655-2026
FDA event ID: 99144
Recalling firm: Lupin Pharmaceuticals, Naples, FL
Brand: Prednisolone Acetate
Manufacturer: Lupin Pharmaceuticals, Inc.
Classification: Class II
Status: Ongoing
Recall initiated: 4 Jun 2026
FDA classified: 30 Jun 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Eye Drops

Timeline

4 Jun 2026	Recall initiated by company
30 Jun 2026	Classified by FDA	+26 days
8 Jul 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Foreign Substance

Product as listed by the FDA

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

Where it was distributed

U.S. Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Presence of Foreign Substance

Which lots are affected?

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.

Where was it sold?

U.S. Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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