Check your steroid drop bottle prescription lot number

FDA Recalls More Than 2.5 Million Bottles of Prednisolone Acetate Eye Drops: What My Patients Need to Know 

The Food and Drug Administration has announced a nationwide recall of prednisolone acetate ophthalmic suspension, a prescription steroid eye drop that many of my patients rely on. A total of 2,530,182 bottles have been pulled from the market because of the presence of a foreign substance in the product. As an ophthalmologist, I want to walk you through what this drop does, why the recall happened, and exactly how to check whether the bottle in your medicine cabinet is one of the affected ones.

Prednisolone acetate 1 percent is one of the most commonly prescribed steroid drops in eye care. We use it to calm inflammation after cataract surgery and other ocular procedures, to treat certain forms of uveitis and iritis, and to quiet inflammation from severe allergic or immune reactions on the surface of the eye. Because it is a suspension, the medication settles and needs to be shaken before each use, and it is meant to be sterile and free of particles. That is precisely why a foreign substance in the bottle is a concern worth taking seriously.

Here are the specifics of the recall. The affected drops were manufactured by Lupin Limited, an India based pharmaceutical company that makes generic medications at its facility in Pithampur, India. The FDA first reported the issue on June 4, 2026, and on June 30, 2026, the agency designated it a Class II recall. A Class II recall means that using the affected product may cause temporary or medically reversible health effects, while the probability of a serious adverse outcome is considered remote. In plain terms, this is a meaningful safety concern that warrants checking your bottle, though it is not the highest tier of danger the FDA assigns.

To find out whether your medication is included, look at the label on your bottle for three pieces of information. First is the National Drug Code, often printed as NDC. Second is the lot code, a short string of letters and numbers. Third is the expiration date. The recall covers 5 mL, 10 mL, and 15 mL bottles of Prednisolone Acetate Ophthalmic Suspension USP, 1 percent, and each size has its own National Drug Code and its own set of affected lots.

For the 5 mL bottles, which carry National Drug Code 70748-332-02, the affected lots are as follows. Lots expiring July 31, 2026 are HA00937, HA00939, HA00941, HA00971, H00973, and HA00975. Lots expiring August 31, 2026 are HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, and HA01048. Lots expiring September 30, 2026 are HA01120, HA01137, HA01129, HA01138, and HA01133. Lots expiring October 31, 2026 are HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, and HA01220. Lots expiring November 30, 2026 are HA01236, HA01238, HA01240, HA01244, HA01246, HA01248, HA01261, HA01263, HA01265, HA01267, HA01278, HA01280, HA01282, HA01284, HA01288, HA01290, HA01292, and HA01298. Lots expiring December 31, 2026 are HB00002, HB00004, HB00006, HB00017, HB00019, HB00021, HB00023, HB00025, HB00031, HB00033, HB00035, HB00037, HB00039, HB00041, and HB00043. Lots expiring January 31, 2027 are HB00049, HB00051, HB00076, HB00078, HB00080, HB00082, and HB00084. Lots expiring February 28, 2027 are HB00128, HB00130, HB00132, HB00134, HB00157, HB00159, HB00161, HB00196, HB00198, and HB00200. Lots expiring March 31, 2027 are HB00224, HB00226, HB00228, HB00230, HB00240, and HB00242. Lots expiring May 31, 2027 are HB00416, HB00417, HB00419, HB00439, HB00441, HB00443, HB00463, and HB00465. The lot expiring June 30, 2027 is HB00561. Lots expiring October 31, 2027 are HB00569, HB00657, HB00659, HB00663, HB00671, HB00673, HB00675, HB00677, and HB00679. Lots expiring November 30, 2027 are HB00747, HB00749, HB00751, and HB00753. Lots expiring December 31, 2027 are HB00761, HB00763, HB00765, HB00783, HB00785, HC00002, HC00004, HC00006, HC00018, HC00020, and HC00028. Lots expiring January 31, 2028 are HC00030 and HC00032. Lots expiring February 29, 2028 are HC00056, HC00058, HC00062, HC00064, HC00073, HC00075, HC00079, HC00081, and HC00083. The lot expiring March 31, 2028 is HC00091.

For the 10 mL bottles, which carry National Drug Code 70748-332-03, the affected lots are as follows. Lots expiring July 31, 2026 are HA00945, HA00947, and HA00949. Lots expiring October 31, 2026 are HA01160, HA01162, and HA01164. Lots expiring November 30, 2026 are HA01234, HA01300, and HA01302. Lots expiring January 31, 2027 are HB00053, HB00055, and HB00057. Lots expiring February 28, 2027 are HB00107, HB00109, HB00111, HB00151, HB00153, and HB00155. Lots expiring May 31, 2027 are HB00386, HB00388, HB00390, HB00445, and HB00447. Lots expiring June 30, 2027 are HB00549, HB00551, HB00553, and HB00555. Lots expiring October 31, 2027 are HB00700 and HB00702. The lot expiring November 30, 2027 is HB00771. Lots expiring December 31, 2027 are HC00008 and HC00010. Lots expiring January 31, 2028 are HC00034, HC00038, HC00054, and HC00060.

For the 15 mL bottles, which carry National Drug Code 70748-332-04, the affected lots are as follows. Lots expiring July 31, 2026 are HA00951, HA00953, and HA00955. Lots expiring October 31, 2026 are HA01188, HA01190, and HA01192. The lot expiring November 30, 2026 is HA01304. Lots expiring January 31, 2027 are HB00113 and HB00115. Lots expiring February 28, 2027 are HB00166 and HB00168. Lots expiring May 31, 2027 are HB00392, HB00394, and HB00396. Lots expiring June 30, 2027 are HB00545 and HB00547. The lot expiring October 31, 2027 is HB00704. The lot expiring November 30, 2027 is HB00773. Lots expiring December 31, 2027 are HC00012 and HC00014. Lots expiring February 29, 2028 are HC00066 and HC00068.

If your bottle matches any of these National Drug Codes, lot codes, and expiration dates, do not simply stop your treatment on your own. Steroid eye drops are often tapered on a deliberate schedule, and stopping abruptly after eye surgery or during active inflammation can allow that inflammation to rebound. Instead, contact your prescribing eye doctor or your pharmacist right away so that a replacement bottle can be arranged and your treatment continues without interruption. Your pharmacist can also help you confirm a match if the printing on your bottle is small or hard to read.

While you continue your drops, pay attention to how your eye feels. If you notice new redness, pain, unusual discharge, sensitivity to light, or any change in your vision, reach out to your eye care provider promptly. These symptoms are worth a same day call. You can also report any problem you believe is connected to a medication to the FDA through its MedWatch program.

I share recalls like this one because part of caring for your eyes is helping you feel confident about what you are putting into them every day. A recall is not a reason to panic, but it is a reason to take two minutes and read the label on your bottle. If you have any doubt at all about whether your prednisolone is affected, bring the bottle to your next visit or call our office and we will check it with you.

This post is for general education and does not replace personalized medical advice. Please consult your own eye doctor or pharmacist about your specific medication and treatment plan.

Sandra Lora Cremers, MD, FACS

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