Pharmaceutical manufacturer Lupin Pharmaceuticals Inc. has initiated a massive voluntary nationwide recall of over 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, an prescription eye drop used to treat eye inflammation, after reports of potential foreign matter contamination.

The recall (Recall Event ID: 99144 / Recall Number: D-0655-2026) was voluntarily initiated by the company on June 4, 2026, and was recently classified by the U.S. Food and Drug Administration (FDA) as a Class II recall on June 30, 2026.

RECALL AT A GLANCE

• Product Affected: Prednisolone Acetate Ophthalmic Suspension, USP, 1% (Sterile)

• Sizes / NDC Numbers:

  • 5 mL (NDC 70748-332-02)

  • 10 mL (NDC 70748-332-03)

  • 15 mL (NDC 70748-332-04)

• Total Quantity: 2,530,182 bottles

• Reason for Recall: Presence of a foreign substance.

• Manufacturer: Lupin Limited (Pithampur, India)

• Distributor / Recalling Firm: Lupin Pharmaceuticals Inc. (Naples, FL)

• Distribution: Nationwide (United States)

• Expiration Dates Affected: July 31, 2026, through March 31, 2028.

WHAT PATIENTS AND PHARMACIES SHOULD KNOW

A Class II classification indicates a situation in which exposure to or use of a violative product may cause temporary or medically reversible adverse health consequences, though the probability of serious adverse health consequences is remote. However, foreign particles in ophthalmic suspensions pose a risk of eye irritation, ocular injury, or infection.

Lupin Pharmaceuticals began notifying direct distributors and consignees via formal letters. The affected lots span across all three bottle sizes (5 mL, 10 mL, and 15 mL) with expiration dates ranging from July 2026 to March 2028.

Patients currently using Prednisolone Acetate Ophthalmic Suspension are advised to check their bottle details or consult their prescribing physician or pharmacist to verify if their specific lot number is affected before continuing use.