Lupin Prednisolone Acetate Eye Drop Recall Investigation

Chimicles Schwartz Kriner & Donaldson-Smith LLP is investigating potential class action claims involving the FDA Class II nationwide recall of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, a prescription steroid eye drop manufactured by Lupin Pharmaceuticals Inc. These eye drops are commonly prescribed to treat inflammation following eye surgery, eye injuries, and noninfectious inflammatory or allergic eye conditions, including swelling, redness, and itching.

What Happened?

On June 4, 2026, Lupin voluntarily recalled more than 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1% due to the reported presence of a foreign substance in the product. On June 30, 2026, the FDA classified the action as a Class II recall, meaning use of the product may cause temporary or medically reversible adverse health consequences.

Neither Lupin nor the FDA has publicly identified what the foreign substance is or how it entered the medication. To date, Lupin has not made any public statement about the recall, including no guidance on how patients may obtain refunds or replacement medication.

What Product Is Covered by the Recall?

The recall covers 5 mL, 10 mL, and 15 mL bottles sold under the following National Drug Codes:

5 mL: NDC 70748-332-02
10 mL: NDC 70748-332-03
15 mL: NDC 70748-332-04

The affected lots carry expiration dates ranging from July 31, 2026 through March 31, 2028. A full list of affected lot numbers is available on the FDA’s Enforcement Report at https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220940.

Who May Be Affected?

You may have relevant information if some or all of the following apply:

You were prescribed and filled Prednisolone Acetate Ophthalmic Suspension, USP, 1%
Your bottle matches one of the NDCs listed above and a lot number identified on the FDA’s recall list
You paid for the medication out of pocket, through insurance co-pay, or via HSA/FSA funds
You experienced any adverse effects (such as eye irritation, redness, pain, discharge, blurred vision, or infection) or were advised by a pharmacist or physician to stop using and replace the medication

What Should You Do?

If you filled a prescription for Lupin Prednisolone Acetate Ophthalmic Suspension, USP, 1%, and believe you may be affected, please contact our attorneys by completing the form below to learn more about your potential legal rights and our ongoing investigation.

Lupin Eye Drop Recall (#941)

This is a questionnaire created by the law firm of Chimicles Schwartz Kriner & Donaldson-Smith LLP (CSK&D) to investigate potential claims related to this investigation. Your answers will be screened, and you may be contacted if your responses match certain criteria.

When you submit this form, it will not automatically collect your details like name and email address unless you provide it yourself.

First Name

Last Name

Address

Address Line 1

City

Zip Code

State:

Phone

Were you prescribed and did you fill a prescription for Prednisolone Acetate Ophthalmic Suspension, USP, 1% manufactured by Lupin Pharmaceuticals Inc.?

What was the prescription intended to treat?

Which bottle size(s) did you receive? (select all that apply)

How did you pay for the medication? (select all that apply)

Did you experience any adverse effects while using this medication? (select all that apply)

Confirm the adverse affects you experienced while using the medication:

Did you receive a recall notification from your pharmacy, doctor, or Lupin?

Have you received a refund or replacement medication from Lupin or your pharmacy?

Please provide any other relevant details:

(*) Indicates required field: When communicating with us through this site or otherwise in connection with a matter for which we do not already represent you, your communication may not be treated as privileged or confidential, and does not create an attorney-client relationship between you and our Firm.

Lupin Prednisolone Acetate Eye Drop Recall Investigation

Haverford Office

Delaware Office

Awards

Site Map