Key Takeaways

  • The FDA has classified the nationwide recall of 2.5 million bottles of Lupin's prednisolone acetate eye drops as a Class II recall due to the presence of a foreign substance
  • The recall affects 5-mL, 10-mL, and 15-mL bottles with specific NDCs and numerous lot numbers expiring between July 2026 and March 2028

More than 2.5 million bottles of prednisolone acetate eye drops manufactured by India-based Lupin Limited have been recalled nationwide. The FDA classified the action as a Class II recall due to the presence of a foreign substance.

According to the FDA's enforcement report, the recall affects 2,530,182 bottles of Prednisolone acetate ophthalmic suspension, USP, 1% packaged in 5-mL, 10-mL, and 15-mL bottles. The recall was initially posted by the FDA on June 4, and the agency designated it a Class II recall on June 30.

Prednisolone acetate ophthalmic suspension is a corticosteroid commonly prescribed to treat ocular inflammation associated with conditions such as postoperative inflammation, uveitis, allergic eye disease, and other inflammatory disorders.

A Class II recall is issued when use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is considered remote.

The recalled products include:

  • 5-mL bottles
    • NDC: 70748-332-02
    • Multiple lot numbers with expiration dates ranging from July 31, 2026, through March 31, 2028
  • 10-mL bottles
    • NDC: 70748-332-03
    • Multiple lot numbers with expiration dates ranging from July 31, 2026, through January 31, 2028
  • 15-mL bottles
    • NDC: 70748-332-04
    • Multiple lot numbers with expiration dates ranging from July 31, 2026, through February 29, 2028

Healthcare providers and patients should refer to the FDA recall notice for the complete list of affected lot numbers corresponding to each bottle size.

Patients using prednisolone acetate ophthalmic suspension should verify the product's National Drug Code (NDC), lot number, and expiration date against the FDA's recall information. Individuals with affected products should contact their ophthalmologist, optometrist, pharmacist, or other prescribing healthcare professional for guidance. 

Lupin Limited manufactures a broad portfolio of generic pharmaceutical products, including ophthalmic medications.