Product Litigation

Prednisolone Acetate Eye Drop Recall: A Timeline of What Happened and What It Means for You 

Posted on by Napoli Shkolnik
eye drop recall blog

More than 2.5 million bottles of a widely prescribed corticosteroid eye drop are now the subject of a nationwide recall, and patients deserve to understand exactly how this unfolded, what risks are involved, and what legal options may be available if they were harmed. 

Below, we break down the recall in a clear timeline, followed by what affected patients should do next. 

What Is Prednisolone Acetate Ophthalmic Suspension? 

Prednisolone acetate ophthalmic suspension, USP, 1% is a corticosteroid eye drop commonly prescribed to treat eye inflammation. Physicians typically prescribe it for: 

  • Postoperative inflammation following eye surgery 
  • Uveitis 
  • Allergic eye disease 
  • Other inflammatory eye conditions 

The medication is manufactured by Lupin Limited, a pharmaceutical company based in India with a broad portfolio of generic drugs, including several ophthalmic products. 

Timeline of the Recall 

June 4, 2026 — Recall Initially Posted The FDA first posted the recall notice for Lupin’s prednisolone acetate eye drops. The action was prompted by the discovery of a foreign substance in the product. 

June 30, 2026 — FDA Classifies the Recall as Class II Nearly a month later, the FDA formally classified the recall as a Class II event. Under FDA guidelines, a Class II classification means using or being exposed to the affected product could cause temporary or medically reversible health problems, or that the chance of serious harm is considered low, but not zero. 

Ongoing — Scope of the Recall Confirmed According to the FDA’s enforcement report, the recall ultimately covers 2,530,182 bottles across three sizes: 

  • 5-mL bottles (NDC 70748-332-02) — lots expiring between July 31, 2026, and March 31, 2028 
  • 10-mL bottles (NDC 70748-332-03) — lots expiring between July 31, 2026, and January 31, 2028 
  • 15-mL bottles (NDC 70748-332-04) — lots expiring between July 31, 2026, and February 29, 2028 

Because the recall spans dozens of lot numbers across three bottle sizes, patients and providers are urged to check the FDA’s full enforcement report for the complete list of affected lots rather than relying on partial summaries. 

It’s not the first time the FDA has had to take action against dangerous eye drops, in 2023  they issued an alert for twenty-six products from the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up and Velocity Pharma. 

What Patients Should Do Now 

If you or a loved one has been using prednisolone acetate ophthalmic suspension, take the following steps: 

  1. Check the NDC number on your bottle against the recalled codes above. 
  1. Check the lot number and expiration date against the FDA’s published list. 
  1. Do not stop treatment abruptly without medical guidance. Contact your ophthalmologist, optometrist, or pharmacist before making any changes. 
  1. Report any adverse symptoms to your healthcare provider immediately, especially eye pain, vision changes, unusual discharge, or signs of infection. 
  1. Document everything, keep the bottle, packaging, receipt, and any records of symptoms or medical visits. 

Could You Have a Legal Claim? 

When a pharmaceutical company distributes contaminated medication, particularly one applied directly to the eye, patients who suffer complications may have grounds for a product liability claim. Potential injuries linked to contaminated ophthalmic products can include eye infections, corneal damage, vision impairment, or worsening of the underlying condition the medication was meant to treat. 

If you experienced any eye-related injury or complication after using a recalled Lupin prednisolone acetate product, an attorney can help you understand whether the manufacturer’s negligence contributed to your harm, and what compensation may be available for medical expenses, lost wages, and pain and suffering. 

Talk to Napoli Shkolnik About Your Recall Rights 

Napoli Shkolnik represents individuals harmed by defective pharmaceuticals, contaminated medical products, and dangerous medical devices nationwide. Our attorneys monitor emerging FDA recalls and litigation involving contaminated medications to help patients understand their legal rights. If you or a family member were affected by the prednisolone acetate eye drop recall, contact Napoli Shkolnik today for a free, confidential consultation to discuss your legal options.  

*Comprehensive recalled lot list:

For 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 

For 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 

For 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