Abbvie Inc.: Pred Mild, Prednisolone Acetate Ophthalmic Suspension, Usp, 0.12%
Recall Summary AbbVie is recalling PRED MILD, a prescription eye drop containing prednisolone acetate 0.12%, because the product failed stability testing and may not maintain its intended strength or safety over time. The recall affects 10 mL bottles distributed nationwide across all U.S. states and Washington, D.C. This is a Class III recall, which means use of the product could cause adverse health effects.
- Recalling firm
- AbbVie Inc.
- Product
- 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
- Failed Stability Specifications
- Classification
- Class III
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-18
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/6139c963-8d1d-48ee-afc2-be284510eedf