Eye Drop Recall 2026: Full List of Recalled Products, Lot Numbers, and What to Do With Yours

Q: Which eye drops are being recalled?

The recall covers Prednisolone Acetate Ophthalmic Suspension USP, 1% — prescription steroid eye drops made by Lupin Limited and distributed nationwide by Lupin Pharmaceuticals. It includes 2,530,182 bottles in 5 mL (NDC 70748-332-02), 10 mL (NDC 70748-332-03), and 15 mL (NDC 70748-332-04) sizes, across dozens of lots with expiration dates from July 2026 into early 2028. The full lot list is in the FDA's enforcement report.

Q: What should I do if I used recalled eye drops?

Don't panic — no confirmed injuries have been reported, and the FDA classifies the risk as temporary or medically reversible. Stop using a bottle from an affected lot, but do not quit a prescribed steroid regimen abruptly; call your eye doctor or pharmacist first, especially after eye surgery. If you notice unusual redness, pain, discharge, or vision changes, contact your doctor and report it to FDA MedWatch at 1-800-FDA-1088.

Q: What does a Class II recall mean?

Class II is the FDA's middle recall tier. It means using the product may cause temporary or medically reversible health problems, while the chance of serious harm is remote. It is less severe than Class I, which is reserved for products likely to cause serious injury or death.

Q: How do I get a refund for recalled eye drops?

Because these are prescription drops, take the bottle (or your prescription info) back to the pharmacy that dispensed it. Pharmacies routinely process recall returns and can arrange a replacement from an unaffected lot or a refund, and coordinate with your insurer on any copay. You can also contact Lupin Pharmaceuticals' customer service for return instructions.

More than 2.5 million bottles of prescription eye drops are being recalled nationwide. Lupin Pharmaceuticals is pulling Prednisolone Acetate Ophthalmic Suspension USP, 1% — a widely prescribed steroid eye drop — after a report of a possible foreign substance in the product, and the FDA has classified it a Class II recall. The one-breath version: check the lot number on your bottle (your pharmacy can do it in seconds), stop using an affected bottle, don't quit your prescription cold without calling your eye doctor, and return the bottle for a replacement or refund. No injuries have been confirmed.

Which Eye Drops Are Being Recalled? The Full List

According to the FDA's enforcement report, the recall covers exactly one product — but a lot of it: 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension USP, 1%, manufactured by India-based Lupin Limited and distributed across the U.S. by Lupin Pharmaceuticals, Inc. It is the generic version of the brand-name drop Pred Forte. Every recalled bottle carries one of three National Drug Codes (NDC):

5 mL bottle: NDC 70748-332-02
10 mL bottle: NDC 70748-332-03
15 mL bottle: NDC 70748-332-04
FDA recall number: D-0655-2026
Lots affected: dozens of lot numbers, with expiration dates running from July 2026 into early 2028 — the complete lot list is published in the FDA's enforcement report

The lot number and expiration date are printed on the bottle label and carton, and your pharmacy can confirm in one phone call whether your bottle came from a recalled lot. Over-the-counter drops like artificial tears are not part of this recall.

Why Were the Eye Drops Recalled?

Lupin initiated the recall on June 4 after a product complaint reported foreign particulate matter — in plain English, visible material that shouldn't be there — in the suspension. Neither the company nor the FDA has publicly identified the substance. Because anything applied directly to the eye must be sterile and particle-free, even a single credible complaint of this kind triggers a broad, precautionary recall; the FDA formally classified it Class II at the end of June, and outlets from The New York Times to ABC News picked it up as it hit the agency's enforcement report.

What Does a Class II Recall Mean?

The FDA sorts recalls into three classes, and Class II is the middle tier. It means using the product might cause a temporary or medically reversible health problem — think irritation or inflammation a doctor can treat — while the probability of serious harm is remote. It is not a Class I, the most serious category reserved for products likely to cause severe injury or death. In short: check your bottle, but don't panic.

What to Do If You Have These Eye Drops

Prednisolone acetate is prescribed for inflammation of the eye — commonly after cataract surgery, or for uveitis and severe allergic flare-ups. That matters, because stopping a steroid taper abruptly can cause rebound inflammation. So follow these steps in order:

Check the lot. Compare the lot number on your bottle or carton against the FDA's recall list, or simply call the pharmacy that filled it.
Stop using an affected bottle — but do not abandon your treatment. Call your ophthalmologist or pharmacist the same day to arrange a replacement, especially if you're recovering from eye surgery.
Get a replacement or refund. Return the bottle to the dispensing pharmacy — recall returns are routine, and the pharmacy can swap in an unaffected lot or refund you and sort out the insurance copay. Lupin's customer service can also provide return instructions.
Report any symptoms. Unusual redness, pain, discharge, light sensitivity, or vision changes after using the drops? Contact your doctor, and report it to FDA MedWatch at 1-800-FDA-1088 or fda.gov/medwatch.

Where Were the Recalled Eye Drops Sold?

The recalled lots were distributed nationwide. Since this is a prescription medication, it reached patients through retail pharmacy counters — including the big national chains — plus mail-order pharmacies, clinics, and eye-care suppliers, rather than store shelves. That's why a call to wherever you filled the prescription is the fastest way to confirm whether your bottle is affected.

Have Any Injuries Been Reported?

Here's the reassuring part: as of the FDA's classification, no confirmed injuries or eye infections have been reported beyond the single complaint that prompted the recall. The action is precautionary — the plausible risk is irritation, inflammation, or a treatable infection, exactly the "temporary or medically reversible" harm the Class II label describes.

How to Check for Future Recalls

The FDA posts recalls at fda.gov/safety/recalls and publishes a searchable weekly enforcement report; you can also sign up for free email alerts. Health investigations often widen after the first announcement — as we've tracked in our CDC food-safety investigation coverage — so it's worth a recheck if you use any recalled product regularly.

Frequently Asked Questions (FAQ)

Which eye drops are being recalled?

Lupin's Prednisolone Acetate Ophthalmic Suspension USP, 1% — 2,530,182 prescription bottles in 5 mL, 10 mL, and 15 mL sizes (NDCs 70748-332-02, -03, -04), across dozens of lots expiring between July 2026 and early 2028. The full lot list is in the FDA's enforcement report.

What should I do if I used recalled eye drops?

Don't panic — no confirmed injuries have been reported. Stop using an affected bottle, but call your eye doctor before stopping a prescribed steroid regimen. Report redness, pain, discharge, or vision changes to your doctor and to FDA MedWatch at 1-800-FDA-1088.

What does a Class II recall mean?

It's the FDA's middle recall tier: the product might cause temporary or medically reversible health problems, while the chance of serious harm is remote. It is less severe than a Class I recall.

How do I get a refund for recalled eye drops?

Return the bottle to the pharmacy that dispensed it — pharmacies process recall returns routinely and can issue a replacement from a safe lot or a refund, and handle your insurance copay. Lupin Pharmaceuticals' customer service can also give return instructions.

Shubham — Writer and Editor

Every article on BoyX News is researched, written and edited by Shubham. There is no content team and no outside contributors. More about how these are written.