PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie co
Summary
The FDA issued a Class III for PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril by AbbVie Inc.. Reason: Failed Stability Specifications.
Details
Source
Drug Recall
External ID
D-0551-2026
Action Date
2026-06-03
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot # 402805, 407596, Exp Date: 08/2026.
Quantity Affected: 2,736 bottles
Reason for Recall
Failed Stability Specifications
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-18
Company
North Chicago, IL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 66 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
AbbVie Inc. has 6 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AbbVie Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AbbVie Inc. have FDA actions?
AbbVie Inc. has 6 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0551-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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