Recall Ledger

PRED MILD recall (AbbVie Inc.)

DrugClass IIIOngoing

Summary: AbbVie Inc. is recalling PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.. Reason: Failed Stability Specifications.

What is being recalled

PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.

Why

Failed Stability Specifications

How serious is it

Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.

Where it was sold

US Nationwide.

How to tell if yours is affected

Lot # 402805, 407596, Exp Date: 08/2026.

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0551-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass III
StatusOngoing
Recall startedMay 18, 2026
ReportedJune 3, 2026
CompanyAbbVie Inc.
Company locationNorth Chicago, IL, United States
Initiated byVoluntary: Firm initiated
Quantity2,736 bottles

More recalls from AbbVie Inc. · all drug recalls · recalls from May 2026

Official FDA record