What Was Recalled?
If you have a bottle of prednisolone acetate eye drops from Lupin, check the NDC number on the label before your next dose. Lupin Pharmaceuticals recalled 2,530,182 bottles after finding a foreign substance in the product.
Prednisolone acetate ophthalmic suspension is a generic corticosteroid drop prescribed to control inflammation in the eye — most often after cataract or corneal surgery, and for uveitis, eye injuries, and allergic or inflammatory conditions of the cornea and conjunctiva. Lupin Limited manufactures it in Pithampur, India, and Lupin Pharmaceuticals distributes it across the United States. It is prescription-only, so it reached patients through pharmacies rather than store shelves.
The recall was posted June 4, 2026, and the FDA classified it on June 30. Bottles carry expiration dates running from July 2026 through March 2028, which is why this is still worth checking now — much of the recalled product has not expired and is sitting in medicine cabinets.
Which Products Are Affected?
All three bottle sizes are recalled, and each has its own National Drug Code.
| Size | NDC |
|---|---|
| 5 mL | 70748-332-02 |
| 10 mL | 70748-332-03 |
| 15 mL | 70748-332-04 |
Dozens of lot numbers are covered, including HA00937, HB00783 and HC00060 — examples rather than the full set.
Why Was It Recalled?
Lupin found a foreign substance in the product. Neither the company nor the FDA has publicly identified what it is.
Eye drops go onto the surface of the eye, which does not have the barriers that protect the digestive tract. Particulate contamination in an ophthalmic product is treated seriously for that reason, and more so in patients whose eyes are already healing from surgery.
The FDA classified this as a Class II recall under recall number D-0655-2026. Class II is the middle tier: it means exposure may cause temporary or medically reversible harm, and that the probability of serious consequences is remote. Class I is reserved for products that can cause serious injury or death, and Class III for those unlikely to cause harm at all.
No illnesses or injuries connected to these drops have been reported.
What Should Patients Do?
- Don’t stop your drops on your own. Steroid eye drops after surgery follow a tapering schedule, and stopping abruptly can allow inflammation to rebound. Call your prescriber first.
- Have your pharmacy check your lot against recall D-0655-2026.
- Ask for a replacement from an unaffected lot if yours is included. Pharmacies keep stock from other lots and other manufacturers.
- Ask about a recall override when you request the replacement.
- Contact your eye doctor about any new pain, redness, discharge, or change in vision.
Refund, Replacement or Repair Information
No consumer refund program has been announced. Lupin’s recall is a market action — product moves back up the supply chain from pharmacies and wholesalers to the company, and patients are not part of that flow.
What you can get is a replacement prescription. Pharmacies routinely swap recalled medication for an unaffected lot without charging a second copay, and many process it as a recall replacement rather than a new fill. That is pharmacy practice rather than a guaranteed Lupin policy, so ask for it explicitly instead of assuming.
The obstacle worth anticipating is your insurer, not your pharmacist. A refill requested days after the last one can be rejected as too early by the plan’s automated limits. Pharmacies can submit a recall or override code to clear that, but they have to know to do it — say the word “recall” when you call.
Lupin Pharmaceuticals can be reached at 239-316-1900 for questions the pharmacy can’t resolve.
Can I Get Money Back?
Not from Lupin, and not through any claim process. The money question that actually arises here is the second copay.
If you already paid a copay for a recalled bottle and the pharmacy charges you again, escalate to the pharmacy manager rather than paying it. If you paid cash instead of using insurance, ask for a credit against the replacement.
A copay on a generic eye drop is typically a small amount, and that is the realistic scale of what is at stake here — the replacement medication matters more than the money.
Where Was It Sold?
The FDA record names no specific chains or states. Prescription drugs move through wholesalers that supply retail, hospital, and clinic pharmacies everywhere, so distribution is recorded as nationwide and nothing narrower. Anyone dispensed this generic during the distribution window could have a recalled bottle.
How to Identify the Recalled Product
The manufacturer’s NDC and lot number are printed on the bottle and the carton. On a dispensed prescription, the pharmacy’s own label often covers the manufacturer’s label, so the numbers may not be visible without peeling anything.
Look for the Lupin name and an NDC beginning 70748-332; drops from another manufacturer aren’t part of this recall.
If the label is obscured, skip the bottle entirely: call the pharmacy that filled it, give them the prescription number, and ask whether the NDC and lot they dispensed appear in recall D-0655-2026. They have both on file and can check in a minute.
What If I Was Harmed?
Tell your eye doctor the bottle may be from a recalled lot, and don’t wait for a routine appointment to do it.
The recall provides no compensation for an office visit, treatment, or a lasting injury.
Keep the bottle rather than discarding it, along with the pharmacy receipt and label. A bottle from an identified lot is the evidence connecting a specific patient to a specific recall.
Legal options exist for people harmed by a defective drug. This page is not legal or medical advice and does not recommend a firm.
How to Report an Incident
Report a reaction or a quality problem to the FDA through MedWatch, or call 1-800-332-1088 for a paper form.
Tell your prescriber as well. Physician reports carry clinical detail that a consumer report usually can’t supply, and both feed the same FDA database.
Official Recall Information
Lupin conducted this recall voluntarily rather than under an FDA order.
The full lot list appears only in the enforcement report database and never in a press release, which is why most coverage of this recall doesn’t reproduce it. The enforcement report entry is searchable by recall number.
A recall stays open until the FDA terminates it, which the agency does once it is satisfied the affected product has been removed. This page will be updated when that happens or if the recall expands.
Frequently Asked Questions
Which eye drops are recalled?
Prednisolone acetate ophthalmic suspension USP, 1%, distributed by Lupin Pharmaceuticals, in 5 mL, 10 mL, and 15 mL bottles under NDCs 70748-332-02, 70748-332-03 and 70748-332-04. Dozens of lots are included, with expiration dates from July 2026 through March 2028.
How do I know if my prednisolone drops are recalled?
Call the pharmacy that filled the prescription and ask whether the NDC and lot they dispensed appear in recall D-0655-2026. The pharmacy’s label often covers the manufacturer’s numbers on the bottle.
Can I get a refund for recalled Lupin eye drops?
Lupin has announced no refund program. Ask your pharmacy to replace the medication with an unaffected lot and to process it as a recall replacement so you aren’t charged a second copay.
Should I stop using my prednisolone eye drops?
Ask your prescriber before stopping. These drops are usually tapered rather than stopped outright, particularly after eye surgery, and your doctor may want you switched to an unaffected lot rather than off the medication.
What was found in the eye drops?
The FDA record describes the presence of a foreign substance without identifying it, and Lupin has not disclosed what it is publicly.
How serious is a Class II recall?
It is the FDA’s middle severity tier, meaning the product may cause temporary or medically reversible health consequences and serious harm is considered unlikely. No injuries have been reported in connection with these drops.
About This Page
RecallRefunds.com is a consumer information site. We are not a recall administrator, a law firm, a government agency, or the manufacturer, and we are not affiliated with Lupin Pharmaceuticals or Lupin Limited. This page summarizes a public drug recall and is general information rather than legal or medical advice. Decisions about your prescription belong with your prescriber and pharmacist.