Abbvie Inc.: Pred Mild, Prednisolone Acetate Ophthalmic Suspension, Usp, 0.12%
Recall Summary AbbVie is recalling PRED MILD eye drops (prednisolone acetate 0.12%) in 10 mL bottles nationwide because the product failed stability testing, meaning it may not maintain its intended strength and safety over time. This is a Class III recall affecting all U.S. states and the District of Columbia. The recalled product was manufactured in France under NDC 11980-174-10.
- 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/6703381b-f2b3-4d6d-b415-6bd6ce03e4cd