HIGH

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.

Failed Stability Specifications

Quick Facts at a Glance

Recall Date
May 18, 2026
Hazard Level
HIGH
Brands
PRED MILD, Allergan, Inc.
Geographic Scope
1 states

Hazard Information

Failed Stability Specifications

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact AbbVie Inc. or your healthcare provider for guidance. Notification method: Letter

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Full 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.. Generic: PREDNISOLONE ACETATE; Brand: PRED MILD. Reason: Failed Stability Specifications. Classification: Class III. Quantity: 2,736 bottles. Distribution: US Nationwide.

Safety Guide

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Product Classification

Product Details

Model Numbers
Lot # 402805
407596
Exp Date: 08/2026.
UPC Codes
11980-174
11980-174-05
11980-174-10
Affected States
ALL
Report Date
June 3, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE