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Drug FDA Class III Ongoing Failed specifications

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.

AbbVie Inc. Published Jun 3, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact AbbVie Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Stability Specifications

Hazards

Failed Stability Specifications · primary

Affected products (1)

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.

PRED MILD · 2,736 bottles

NDC: 11980-174, 11980-174-05, 11980-174-10
Lot codes: 402805
Code info: Lot # 402805, 407596, Exp Date: 08/2026.

Affected areas

Nationwide

Timeline

  1. Initiated
    May 18, 2026
  2. Published
    Jun 3, 2026
Recall number
D-0551-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.