The U.S. Food and Drug Administration has announced a nationwide recall of more than 2.5 million bottles of prednisolone acetate ophthalmic suspension 1%, a steroid eye drop manufactured by Lupin Limited. The FDA classified the action as a Class II recall after a foreign substance was found in the product — a designation meaning any potential health effects are expected to be temporary or reversible, and the risk of serious harm is considered remote.
Prednisolone acetate is one of the most commonly prescribed eye drops in ophthalmology. Many of our patients use it after cataract surgery, LASIK, or other procedures, or to manage inflammatory conditions such as uveitis and allergic eye disease. If you are currently using prednisolone drops — or have a bottle in your medicine cabinet — we recommend taking a moment to check whether yours is affected.
How to check your bottle
The recall applies only to Lupin-manufactured bottles with these National Drug Codes (NDCs), printed on the label and box:
5 mL bottles — NDC 70748-332-02
10 mL bottles — NDC 70748-332-03
15 mL bottles — NDC 70748-332-04
Multiple lot numbers are included, with expiration dates falling between July 2026 and March 2028. Because the list of affected lots is long, please compare your bottle’s NDC, lot number, and expiration date against the official FDA recall notice rather than relying on the summary above.
For more information:
FDA Enforcement Report — Prednisolone Acetate Recall Details
Eyewire+ news coverage of the recall
What to do if your bottle is affected
Do not simply stop using your drops on your own; steroid eye medications often need to be tapered or replaced, especially after surgery. If your bottle matches a recalled NDC and lot number, or if you’re unsure how to read the label, call our office and we will help you verify your medication and arrange a replacement prescription if needed.
Princeton Eye Group patients can reach us at any of our locations:
Princeton: 609-921-9437
Monroe: 609-655-8808
Somerset: 732-565-9550
As always, contact us promptly if you experience new eye pain, redness, discharge, or a change in vision while using any eye medication.