D-0551-2026 Class III Ongoing

Recalled by AbbVie Inc. — North Chicago, IL

FDA drug recall D-0551-2026 was initiated by AbbVie Inc. on May 18, 2026 and is designated Class III. Reason for recall: Failed Stability Specifications The recall status is ongoing. Affected quantity: 2,736 bottles.

Recall Details

Product Type
Drugs
Report Date
June 3, 2026
Initiation Date
May 18, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,736 bottles

Product 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.

Reason for Recall

Failed Stability Specifications

Distribution Pattern

US Nationwide.

Code Information

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