Prednisolone Acetate Ophthalmic Suspension, USP

Lupin Limited has recalled Prednisolone Acetate Ophthalmic Suspension, USP, according to the U.S. Food and Drug Administration (FDA). The recall was announced on July 6, 2026 and was initiated on May 18, 2026. The FDA has not yet assigned it a severity classification — that usually follows the initial announcement by several weeks.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Prednisolone Acetate Ophthalmic Suspension, USP, with approximately 2,530,182 bottles affected. The company behind the recall is Lupin Limited, based in Nationwide. The FDA describes the product as: “Prednisolone Acetate Ophthalmic Suspension, USP, 1% (steroid eye drops) in 5 mL, 10 mL, and 15 mL bottles; more than 2.5 million bottles distributed nationwide”

Why was Prednisolone Acetate Ophthalmic Suspension, USP recalled?

According to the FDA, the stated reason for the recall is: “Presence of a foreign substance found in the eye drops. The recall covers 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, manufactured in Pithampur, India, and was initiated May 18, 2026. Prescription steroid eye drops of this kind are used to treat eye inflammation; steri….” In plain terms, this recall relates to foreign material.

A foreign material recall means that pieces of something which should not be in food — such as metal, plastic, or glass — may be present. These can pose a choking hazard or cause injury. Recalls like these are issued to remove the affected product before anyone is hurt.

What should you do?

If you think you may have bought Prednisolone Acetate Ophthalmic Suspension, USP, compare it against the product description and identifying codes (Prescription eye drops — if you use prednisolone acetate 1% drops, check with your pharmacist to confirm whether your bottle is affected before stopping any pr…) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Lupin Limited or your local health authority.

About this recall

This recall was distributed in Nationwide. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.