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FDA Recall of Prednisolone Eye Drops

The U.S. Food and Drug Administration (FDA) has announced a recall of certain lots of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, a prescription steroid eye drop commonly used to reduce inflammation after eye surgery and treat other inflammatory eye conditions.

If you’re a patient of Denver Eye Surgeons and have recently been prescribed prednisolone eye drops, it’s important to review the FDA recall notice to determine whether your medication is included.

Which Eye Drops Are Being Recalled?

The recall applies only to specific lots of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, manufactured by Lupin Limited. Not every bottle of prednisolone eye drops is included.

The FDA has classified this as a Class II recall, meaning the affected product could potentially cause temporary or treatable health effects. According to the FDA, the risk of serious health consequences is considered low.

Why Were the Eye Drops Recalled?

According to the FDA, the recall was initiated because of the potential presence of a foreign substance in certain bottles of the medication.

The recall was issued out of an abundance of caution to help protect patient safety.

What Should Patients Do?

If you currently use prescription prednisolone eye drops, check your medication to determine whether it is included in the recall.

If your eye drops are on the recall list, contact the prescribing physician for a replacement.

To view the complete list of affected lot numbers and expiration dates, visit the FDA’s official recall announcement.

Our Commitment to Patient Safety

Medication recalls can understandably be concerning, but they are an important part of ensuring the safety of patients. We encourage all patients using prescription eye medications to stay informed about FDA safety announcements and recalls.

Patient safety is our highest priority. If you have questions about your prescribed eye medication or need to schedule a follow-up appointment, the team at Denver Eye Surgeons is here to help.