Lupin Pharmaceuticals Inc.: Prednisolone Acetate Ophthalmic Suspension, Usp, 1%
Recall Summary Lupin Pharmaceuticals is recalling prednisoLONE Acetate Ophthalmic Suspension 1% eye drops in 5 mL, 10 mL, and 15 mL bottles nationwide because a foreign substance was found in the product. This is a prescription medication used to treat eye inflammation. The recall affects patients across all U.S. states and the District of Columbia who received this medication.
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product
- prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA
- Reason
- Presence of Foreign Substance
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-04
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/86356c3b-204a-4003-a1d6-991813e36110