Pred Mild Suspension/ Drops
FDA Recall NDC 11980-174
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pred Mild (NDC 11980-174). A significant event, classified as Class III, was initiated on May 18, 2026 by Allergan, Inc.. The reported reason for this action was: "Failed Stability Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Stability Specifications
May 18, 2026
Jun 03, 2026
2,736 bottles
Recall Profile & Regulatory Data
Event ID
99008
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
AbbVie Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
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.
Batch or Lot Expiration Information
Lot# 402805, 407596, Exp Date: 08/2026.
Affected Packages Involved in this Recall
11980-174-05Product
11980-174-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
