FDAClass III · Drug · Recalled June 3, 2026

PRED MILD recall — AbbVie Inc.

Hazard: Failed Stability Specifications

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0551-2026
Brand: AbbVie
Classification: Class III
Units affected: 2,736 bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.

Affected products

PRED MILD

Companies & origin

Recalling firm location: North Chicago, IL, United States
Firm address: 1 N Waukegan Rd, 60064-1802

Identifying details (verbatim from the notice)

Product codes / lots: Lot # 402805, 407596, Exp Date: 08/2026.
Distribution: US Nationwide.
Firm notified the public via: Letter
FDA event ID: 99008
Recall initiated: May 18, 2026
FDA classified: May 27, 2026
FDA report date: June 3, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

Report a data error on this page