AbbVie Inc Faces FDA Enforcement Action For Pred Mild Recall

AbbVie Inc. has issued the following enforcement report: 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. Product Quantity: 2,736 bottles.

Recall Number: D-0551-2026. Code Information: Lot # 402805, 407596, Exp Date: 08/2026. Classification: Class III.

Event Details. Event ID: 99008. Voluntary /Mandated: Voluntary: Firm initiated.

Product Type: Drugs. Initial Firm Notification of Consignee or Public: Letter. Status: Ongoing.

Distribution Pattern: US Nationwide. Recalling Firm: AbbVie Inc. Center Classification Date: May 27, 2026. Recall Initiation Date: May 18, 2026.