FDA recall D-0551-2026

Product

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 for recall

Failed Stability Specifications

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2026-05-18

Report date

2026-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0551-2026