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Class II · ModerateActive recall

Prednisolone Acetate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: 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 it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Foreign Substance

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Pithampur (M.P) 454 775, INDIA foreign manufacturer
Brand namePREDNISOLONE ACETATE
Generic namePREDNISOLONE ACETATE
Active ingredient(s)PREDNISOLONE ACETATE
Distributed by / forLupin Pharmaceuticals Inc.
NDC70748-332-02
Show the full FDA record
Full product labelprednisoLONE 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 firmLupin Pharmaceuticals Inc.
DistributionU.S. Nationwide
Quantity2,530,182 bottles
Recall initiated2026-06-04
Report date2026-07-08
Recall completed—
Recall numberD-0655-2026
ClassificationClass II
FDA statusOngoing
Origin on fileNaples FL United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.