Lupin Pharmaceuticals has initiated a voluntary recall of more than 2.5 million bottles of prednisolone acetate ophthalmic suspension, USP, 1%. The prescription eye drops are being pulled due to a "foreign substance."
A full list of the recalled eye drops is here.
Jeffrey H. Ma is an ophthalmologist at the UC Davis Eye Center. He specializes in diseases that affect the surface layers of the eye. He routinely prescribes prednisolone acetate for his patients.
"Prednisolone is a corticosteroid eye drop. It is one of the most widely prescribed topical corticosteroid eye drops," Ma said. "It is commonly used to treat inflammatory eye conditions, such as iritis and uveitis, which are a group of diseases that cause inflammation of the iris and other surrounding structures inside the eye."
Prednisolone acetate is routinely prescribed after most ophthalmic surgeries, including cataract surgery, he noted.
How long the drops are used — and how often — depends on the condition being treated.
People prescribed prednisolone acetate for inflammatory eye conditions may need to use the eye drops several times a day for several weeks or months, Ma said. Other patients, such as those who are recovering from a corneal transplant, may need to use corticosteroid drops indefinitely.
"People using topical prednisolone acetate drops manufactured by Lupin Pharmaceuticals should check their vials to see if they are on the recall list," Ma said. "If the drops are on the recall list, they should immediately contact the prescribing physician for a replacement."
He noted that prednisolone acetate eye drops not on the recall list or not manufactured by Lupin Pharmaceuticals should be safe to use.
Previous eye drop recalls have been for over-the-counter drops
This current prescription eye-drop recall follows multiple recalls of over-the-counter products in recent years. In April 2026, more than 3 million over-the-counter lubricating eye drops were recalled. In 2023, recalled eye drops were associated with four deaths, 14 cases of vision loss and 80 infections.
There have been no reports of adverse events related to the prednisolone recall.
Gary Novack is a clinical professor in the UC Davis Department of Ophthalmology & Vision Science. He is a board-certified clinical pharmacologist and a consultant in ophthalmic product development.
"Prednisolone acetate is a suspension, rather than a solution," Novack said. He explained that the product is "micronized," meaning the active medication is ground down into tiny particles through a mechanical milling process.
The suspension of the medication is why instructions for prednisolone often say to shake the bottle before using.
Novack agrees with Ma that people should not stop using eye drops prescribed by their doctor if they are not on the recall list.
Although product recalls are distressing, Novack found it reassuring that the company had initiated the voluntary recall.
"This is a standard part of the quality-control process. It shows the system to protect people who use these products is working," Novack said.
How to check your eye drops
Lot numbers and expiration dates for the recalled Lupin Pharmaceuticals eye drops are listed below and are available on the FDA website.
Product Description
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.
Product Quantity Recalled: 2,530,182 bottles
Recalled Lots
a) 5 mL
Expires: 7/31/2026
HA00937, HA00939, HA00941, HA00971, H00973, HA00975
Expires: 8/31/2026
HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, HA01048
Expires: 9/30/2026
HA01120, HA01137, HA01129, HA01138, HA01133
Expires: 10/31/2026
HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, HA01220
Expires: 11/30/2026
HA01236, HA01238, HA01240, HA01244, HA01246, HA01248, HA01261, HA01263, HA01265, HA01267, HA01278, HA01280, HA01282, HA01284, HA01288, HA01290, HA01292, HA01298
Expires: 12/31/2026
HB00002, HB00004, HB00006, HB00017, HB00019, HB00021, HB00023, HB00025, HB00031, HB00033, HB00035, HB00037, HB00039, HB00041, HB00043
Expires: 1/31/2027
HB00049, HB00051, HB00076, HB00078, HB00080, HB00082, HB00084
Expires: 2/28/2027
HB00128, HB00130, HB00132, HB00134, HB00157, HB00159, HB00161, HB00196, HB00198, HB00200
Expires: 3/31/2027
HB00224, HB00226, HB00228, HB00230, HB00240, HB00242
Expires: 5/31/2027
HB00416, HB00417, HB00419, HB00439, HB00441, HB00443, HB00463, HB00465
Expires: 6/30/2027
HB00561
Expires: 10/31/2027
HB00569, HB00657, HB00659, HB00663, HB00671, HB00673, HB00675, HB00677, HB00679
Expires: 11/30/2027
HB00747, HB00749, HB00751, HB00753
Expires: 12/31/2027
HB00761, HB00763, HB00765, HB00783, HB00785, HC00002, HC00004, HC00006, HC00018, HC00020, HC00028
Expires: 1/31/2028
HC00030, HC00032
Expires: 2/29/2028
HC00056, HC00058, HC00062, HC00064, HC00073, HC00075, HC00079, HC00081, HC00083
Expires: 3/31/2028
HC00091
b) 10 mL
Expires:7/31/2026
HA00945, HA00947, HA00949
Expires: 10/31/2026
HA01160, HA01162, HA01164
Expires: 11/30/2026
HA01234, HA01300, HA01302
Expires: 1/31/2027
HB00053, HB00055, HB00057
Expires: 2/28/2027
HB00107, HB00109, HB00111, HB00151, HB00153, HB00155
Expires: 5/31/2027
HB00386, HB00388, HB00390, HB00445, HB00447
Expires: 6/30/2027
HB00549, HB00551, HB00553, HB00555
Expires: 10/31/2027
HB00700, HB00702
Expires: 11/30/2027
HB00771
Expires: 12/31/2027
HC00008, HC00010
Expires: 1/31/2028
HC00034, HC00038, HC00054, HC00060
c) 15 mL
Expires: 7/31/2026
HA00951, HA00953, HA00955
Expires: 10/31/2026
HA01188, HA01190, HA01192
Expires: 11/30/2026
HA01304
Expires: 1/31/2027
HB00113, HB00115
Expires: 2/28/2027
HB00166, HB00168
Expires: 5/31/2027
HB00392, HB00394, HB00396
Expires: 6/30/2027
HB00545, HB00547
Expires: 10/31/2027
HB00704
Expires: 11/30/2027
HB00773
Expires: 12/31/2027
HC00012, HC00014
Expires: 2/29/2028
HC00066, HC00068
