- Over 2.5 million bottles of prednisolone acetate eye drops have been recalled nationwide.
- The FDA warns that the eye drops were recalled due to the “presence of a foreign substance.”
- If your medication has been affected, consult with your healthcare provider on next steps.
If you take prescription eye medication, you may want to check your medicine cabinet. A total of 2,530,182 bottles of prednisolone acetate eye drops—a medication commonly used to treat allergies and eye inflammation—have been recalled nationwide due to the “presence of a foreign substance,” according to the Food and Drug Administration (FDA).
The affected eye drops were manufactured by Lupin Limited, an India-based pharmaceutical company that specializes in generic drugs. After first issuing a report about Lupin Limited’s prednisolone acetate eye drops on June 4, the FDA labeled the recall Class II on June 30. In Class II recalls, affected products may cause temporary, reversible health effects.
Worried your medication may be affected? Check your prednisolone acetate eye drops against the information below.
How to tell if your eye drops are affected
The recall includes bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, in 5-mL, 10-mL, and 15-mL bottles. Check your products against the National Drug Codes (NDCs), lot codes, and expiration dates listed below.
5-mL bottles
NDC: 70748-332-02
Lot codes and expiration dates: 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
10-mL bottles
NDC: 70748-332-03
Lot codes and expiration dates: 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
15-mL bottles
NDC: 70748-332-04
Lot codes and expiration dates: 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
What to do with recalled products
If your eye drops are affected by the recall, consult with your healthcare provider or pharmacist on next steps. Do not stop taking prescription medication without the advice of a healthcare professional.
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